Ongoing clinical studies at the IHU
Transparency Portal
Strasbourg’s Institut Hospitalo-Universitaire (IHU) is committed to promoting openness and trust in the field of medical research, in order to improve science and public health. The aim of this Transparency Portal is to provide you with clear and transparent information about the IHU Strasbourg’s clinical studies, both current and past. The data collected during these studies may subsequently be used anonymously for scientific research with a different purpose or to help develop software for commercial purposes.
The protection of your personal data is of the utmost importance to us. Full details of how we use your data and your rights in this respect are available in our privacy policy.
For each clinical study, you will find the following information:
- The name of the principal investigator or project leader,
- The main objective of the study,
- The population involved,
- The expected study completion date,
- The date of the regulatory authority’s approvals,
- The « clinicaltrials.gov» reference number if applicable,
- The information notice for patients.
Ongoing Studies
ENDOSLEEVE - TREATMENT OF MORBID OBESITY BY ENDOSCOPIC GASTRIC TUBULIZATION
Principal Investigator: Pr. Silvana PERRETTA
Main Objective: The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization. These data are usually collected during medical consultations and will enable the assessment of weight loss, quality of life and comorbidities improvement, reproducibility, and durability of the technique.
Study population: This study involves patients who will undergo an endoscopic gastric tubulization.
Expected study completion date: June 2026
Ethical committee approval: 19/03/2018
N° NCT: NCT03554902
ESG IRM - ASSESSMENT OF THE IMPACT OF ENDOSCOPIC GASTRIC REVISION BY APPLICATION OF ADDITIONAL SUTURES ON WEIGHT LOSS AFTER ENDOSCOPIC SLEEVE GASTROPLASTY IN OBESE PATIENTS
Principal Investigator: Pr. Silvana PERRETTA
Main Objective: The main objective is to assess the benefits of a revision during the follow-up of endoscopy patients who present a TWL <10% or a BMI greater than 30 at 6 months from the primary ESG.
Study population: This study involves all patients support for obesity in the Digestive and Endocrine Surgery Department of the Strasbourg’s NHC
Expected study completion date: September 2026
Ethical committee approval: 01/04/2021
N° NCT: NTC04945473
PICO - RANDOMISED TRIAL OF COMPREHENSIVE, INTENSIVE, ON-SITE BEHAVIOURAL LIFESTYLE INTERVENTION VERSUS USUAL CARE DURING THE PREOPERATIVE PREPARATION FOR BARIATRIC SURGERY
Principal Investigator: Dr. Michel VIX
Main Objective: The main objective is to compare weight loss for 2 years after surgery.
Study population: This study involves patient with a BMI (Body Mass Index) of 40 or BMI of 35 with associated comorbidity and who wish to undergo obesity surgery.
Expected study completion date: September 2028
Ethical committee approval: 24/02/2020
N° NCT: NCT04282304
MONIREA - USE OF RDS MULTISENSE® IN POST-ICU PATIENTS IN THE COVID-19 ERA
Principal Investigator: Pr. Julien POTTECHER
Main Objective: The aim of this study is to assess the relevance and reliability of an innovative clinical signs surveillance system, such as the MultiSense®-Strip Patch, during the monitoring of patients cared for in a post-ICU rehabilitation unit during both rest and exercise during the COVID-19 era.
Study population: This study involves all patients transferred from the ICU to the post-ICU in the Anesthesia Critical Care & Perioperative Medicine (Hautepierre Hospital, Strasbourg and Central Hospital, Nancy).
Expected study completion date: March 2025
Ethical committee approval: 27/11/2020
ANSM authorization: 06/11/2020
N° NCT: NCT04661423
FOREGUT - PROSPECTIVE STUDY OF THE CONTRIBUTION OF FLUORESCENCE IN THE GUIDANCE OF LYMPHADENECTOMY AND IN PEROPERATIVE EVALUATION OF PRE-ANASTOMOTIC TISSUE PERFUSION IN LAPAROSCOPIC OESOGASTRIC ONCOLOGIC RESECTIONS
Principal Investigator: Pr Silvana PERRETTA
Main Objective: The aim of the study is to assess the impact of Infracyanine Green (ICG) and near infra-red (NIR) fluorescence imaging guidance in terms of number of lymph nodes resected and quality of gastrointestinal tract anastomoses in esophagogastric cancer surgery.
Study population: This study involves adult patients, male or female with resectable primitive esophageal or gastric cancer for whom a surgical resection is planned.
Expected study completion date: April 2026
Ethical committee approval: 18/01/2021
ANSM authorization: 18/12/2020
N° NCT: NCT04734821
EVENCIPOR - EVALUATION OF MINIMAL HEPATIC ENCEPHALOPATHY IN PATIENTS WITH CIRRHOSIS AND PORTAL HYPERTENSION
Principal Investigator: Dr. Simona TRIPON
Main Objective: The main objective is to assess presence of MHE (minimal hepatic encephalopathy) in patients with cirrhosis and portal hypertension”
Study population: This study involves patients with cirrhosis and portal hypertension who underwent a CT scan or MRI in the last 3 months and are over 18 years old.
Expected study completion date: March 2026
Ethical committee approval: 16/12/2020
N° NCT: NCT04807803
ECHOSURG - NON-RANDOMIZED PROSPECTIVE STUDY FOR INTRAOPERATIVE ENDOSCOPIC ULTRASOUND WITH FINE NEEDLE BIOPSY FOR THE DIAGNOSIS OF METASTATIC LESIONS OF OPERATIVE PANCREATIC CANCER
Principal Investigator: Pr. Patrick PESSAUX
Main Objective: The main objective is to estimate the sensitivity and specificity of a simple classification “benign / malignant” of the nodes, established by the endoscopist using endoscopic ultrasound criteria, compared to the gold standard (anatomopathology).
Study population: This study involves adult patients, male or female, with a solid or cystic pancreatic tumor and for whom a surgical resection is planned.
Expected study completion date: December 2025
Ethical committee approval: 15/04/2021
N° NCT: NCT04899739
BARAMBU - EVALUATION OF THE HOSPITAL-CITY NETWORK TO OUTPATIENT BARIATRIC SURGERY
Project Leader: Dr. Michel VIX
Main Objective: The main objective is to create and assess a secure model of the hospital-city network to outpatient bariatric surgery.
Study population: This study involves patients, male or female, for whom a bariatric ambulatory surgery is planned.
Expected study completion date: April 2026
LYNOP - LYMPH NODE PROTOCOL – VERY HIGH-RESOLUTION IMAGING OF NORMAL AND METASTATIC LYMPH NODES
Project Leader: Dr. Aïna VENKATASAMY
Main Objective: The objective of the study is to evaluate the interest of high-resolution ultrasound for the detection of lymph node micro- and macro-metastases, compared to high-resolution 7 T MRI, OCT and histology as gold standard.
Study population: This study involves patients, male or female, undergoing either an intervention including the removal of normal lymph nodes, not analyzed in clinical routine (examples: benign pathologies such as Sleeve, cholecystectomy, sigmoidectomy, etc.), or cancer surgery with resection lymph node (ENT, lung, digestive or gynecological cancers)
Expected study completion date: April 2026
HDH reference: F20211007150620
Ethical committee approval: 15/06/2022
ENS - IMMUNOHISTOLOGICAL AND MOLECULAR CHARACTERISATION OF EPITHELIA FROM THE HEALTHY AND PATHOLOGICAL DIGESTIVE TRACT TAKEN AND IN EX VIVO CULTURE
Project Leader: Dr. Aïna VENKATASAMY
Main Objective: The objective of the study is to characterise healthy and pathological digestive epithelia using a range of image analyses / analyses at cellular / molecular tissue level.
Study population: This study involves patients, male or female, undergoing either a surgery with removal of the colon, in the context of colon cancer or ovarian cancer, AND not having been treated with chemotherapy (Group 1); or a surgery with removal of the colon for ovarian cancer and having been treated with chemotherapy (Group 2); or a surgery involving removal of the colon as part of an inflammatory colon disease (e.g. sigmoiditis or Crohn’s disease (Group 3)).
Expected study completion date: September 2025
HDH reference: F20220113140232
Ethical committee approval: 15/06/2022
5G-OR1 - VIRTUALISATION AND MEASUREMENT OF DATA FROM OPERATING ROOM EQUIPMENT DURING A MINIMALLY INVASIVE SURGICAL PROCEDURE
Project Leader: Dr. Alain GARCIA
Main Objective: The main objective is to determine the data flow, in terms of types and volume of data, generated during a minimally invasive operation.
Study population: Adult patients, male or female, undergoing programmed minimally invasive surgery known as “simple” (laparoscopic cholecystectomy, laparoscopic inguinal hernioplasty) or “complex” (bariatric surgery: sleeve gastrectomy and gastric bypass, colorectal surgery: left colectomy or procto sigmoidectomy).
HDH reference: F20220718110450
MONIT-OR1 - MULTIMODAL CAPTURE OF DIGITAL DATA IN THE OPERATING ROOM DURING A MINIMALLY INVASIVE SURGICAL PROCEDURE
Project Leader: Dr. Alain GARCIA
Main Objective: The aim of this study is to advance the development of intelligent systems capable of providing surgical assistance (based on the holistic exploitation of digital data available in the operating room) but also capable of producing surgical reports augmented with surgical video sequences automatically extracted from the recordings made.
Study population: Adult patients, male or female, undergoing robot-assisted laparoscopic surgery for one of the following procedures: Benign pathologies (cholecystectomy; abdominal wall hernia repair: Inguinal hernioplasty, Abdominal wall hernioplasty; Appendicectomies (excluding instability)); Total, left and right colectomies (and variants); Oncological gastrectomies; Total or partial gastrectomy; Anti-reflux/bariatric surgery (gastric fundoplicature, bariatric surgery (sleeve gastrectomy and gastric bypass)); Hepatectomies (hepatic segmentectomy, hepatic biopsy); Pancreatectomies (distal pancreatectomy, laparoscopic duodenopancreatectomy); Laparoscopic splenectomy.
HDH reference: F20220715162605
Completed studies
COLON AMBU - CLINICAL AND ECONOMIC EVALUATION OF COLORECTAL SURGERY IN OUTPATIENT CARE
Principal Investigator: Pr. Didier MUTTER
Main Objective: The main objective is to assess the medical and economic benefit of outpatient care for colorectal surgery in a university hospital center.
Study population: This study involves patients who will undergo colon surgery and who qualify for outpatient surgery regardless of their pathology.
Study completion date: November 2024
Ethical committee approval: 09/11/2018
ANSM authorization: 07/06/2018
N° NCT: NCT03760939
STARHE - RISK STRATIFICATION OF HEPATOCARCINOGENESIS USING A DEEP LEARNING BASED CLINICAL, BIOLOGICAL AND ULTRASOUND MODEL IN HIGH-RISK PATIENTS
Principal Investigator: Dr. Jérémy DANA
Main Objective: The main objective is to stratify the risk of hepatocarcinogenesis in patients with advanced chronic liver disease.
Study population: This clinical study will include adult patients with advanced chronic liver disease eligible to hepatocellular screening according to the European Association for the Study of the Liver (EASL) guidelines but with no history of treated hepatocellular carcinoma.
Study completion date: September 2024
Ethical committee approval: 04/05/2021
N° NCT: NCT04802954
APEUS-NAV1 - FIRST-IN-HUMAN NAVIGATION EUS SYSTEM CLINICAL STUDY
Principal Investigator: Dr. Léonardo SOSA-VALENCIA
Main Objective: the main objective is to evaluate the EUS navigation system’s procedure duration compared to standard procedure times.
Study population: This study involves adult patients, male or female, for whom a EUS procedure for pancreatic disease is programmed within the frame of their clinical care.
Study completion date: October 2024
ANSM authorization: 26/08/2022
Ethical committee approval: 25/07/2022
N° NCT : NCT05515705
MDS1 OSSICLEAR - FEASIBILITY STUDY ON SOUNDUCT NON-INVASIVE BONE AND CARTILAGE CONDUCTION HEARING AIDS
Principal Investigator: Pr. Christian DEBRY
Main Objective: The primary objective of this investigation is to demonstrate objective tonal and vocal hearing improvement by audiometry with the MDS1 Ossiclear solution fitting versus bare ears, in silence and in noise, with adjustment.
Study population: Patients of both sexes, presenting all type of deafness without any particular restriction.
Study completion date: July 2024
ANSM authorization: 15/11/2023
Ethical committee approval: 25/01/2024
ACACIAS 2 - LEARNING CANCER ANNOUNCEMENT CONSULTATION BY SIMULATION
Project Leader: Dr. Élise DELUCHE (CHU Limoges, AOMR)
Main Objective: The main objective is to evaluate the evolution of stress in young doctors during the announcement consultation between D0 (before the start of training) and M5 (at the end of 5 months of training).
Study population: This study involves medical interns, assistants and residents.
Study completion date: October 2024
HDH reference: F20221011092723
IMANEUS - IMAGE ANALYSIS FOR ENDOSCOPIC ULTRASOUND
Project Leader: Leonardo SOSA-VALENCIA
Main Objective: The main objective is to collect medical images (echo-endoscopy, MRI and scanner) from 2018 to 2021 in order to provide a computer-aided diagnosis system.
Study population: This study involves adult patients, male or female, who underwent a pancreatic echo-endoscopy in the Digestive and Endocrine Surgery Department of the Strasbourg’s NHC
Ethical committee approval: 10/11/2020
HDH reference: F20201015130911
APEUS-AI1 - AUGMENTED PANCREATIC ENDOSCOPIC ULTRASOUND ASSISTED BY ARTIFICIAL INTELLIGENCE
Project Leader: Dr. Léonardo SOSA-VALENCIA
Main Objective: The main objective is to carry out a proof of concept of the use of an AI-based tool to detect in real time:
- The pancreatic parenchyma and its ultrasound characteristics,
- The part of the visualized pancreas (head, body, tail).
Study population: This study involves patients, male or female, undergoing or having undergone a pancreatic echo-endoscopy in the digestive surgery department of the NHC Strasbourg
HDH reference: F20220309161612
SAFECHOLE - SURGICAL DATA SCIENCE FOR SAFE LAPAROSCOPIC CHOLECYSTECTOMY
Project Leader: Pietro MASCAGNI
Main Objective: The present data collection is aimed at studying the correlation between clinical information, surgeons’ behaviour and intraoperative events quantified in surgical videos by means of advanced analytics. Altogether, this work will inform on best practices for safe laparoscopic cholecystectomy.
Study population: This study involves patients undergoing laparoscopic cholecystectomy at Nouvel Hôpital Civil, Strasbourg, France, from June 2014 to June 2021
Ethical committee approval: 10/11/2020
HDH reference: F20200730144229
ENDOMETRE IA - AUTOMATED STAGING OF ENDOMETRIAL CANCER USING AN MRI BASED DEEP LEARNING MODEL
Project Leader: Dr. Lise LECOINTRE
Main Objective: The objective of the study is to determine the diagnostic performance of an artificial intelligence model (deep learning (DL) or radiomics) in the evaluation of the depth of myometrial invasion (MI) and cervical stroma, as well as the histological grade on the MRI of endometrial cancer.
Study population: This study involves female patients with endometrial cancer whose initial workup contains an accessible pelvic MRI.
Study completion date: June 2024
HDH reference: F20220518093243
CANCER PROFILE - PREDICTIVE AND PERSONALIZED MEDICINE OF PANCREATIC CANCER
Project Leader: Pr. Patrick PESSAUX
Main Objective: The main objective is to improve the diagnosis and subsequent prediction of tumor response to treatments, using histological imaging and artificial intelligence (AI)-assisted personalized functional profiling to support the medicine of precision in the field of pancreatic duct adenocarcinoma (PDAC).
Study population: This study involves patients, male or female, undergoing a scheduled pancreatic surgery with pancreatic resection.
HDH reference: F20220413120650