Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
72 participants
INTERVENTIONAL
2017-09-05
2020-03-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Feasibility of an Endoluminal-suturing Device (Endomina TM) for Gastric Reduction
NCT02534662
Prospective Multicenter Study With the Endomina® Triangulation Platform
NCT05677464
Endoscopic Sutured Gastroplasty with Endomina® Device Versus Standard of Care in Patients with Type 2 Diabetes and Class I Obesity: a Multi-center, Randomized Controlled Trial
NCT05516576
Use of an Endoluminal-suturing Device for Endoscopic Gastric Reduction as an Aid for Class I Obesity, or Class II Obesity Without Comorbidity
NCT03900481
A Prospective Study to Evaluate the Suture Pattern With the Endomina Suturing Device for Endoscopic Sutured Gastroplasty (ESG).
NCT03843801
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This latter technique is the most common and most effective surgical procedure performed worldwide and has been processed to be an effective treatment of morbid obesity and its complications, achieving excess weight loss of 65 to 80 %; 1-2 years after surgery.
Vertical gastric plication is a novel surgical approach for reducing the stomach capacity. Anterior surface plication and greater curvature plication are variations of vertical gastric plication that reduce the gastric capacity through infolding of the anterior surface or greater curvature of the stomach, respectively. These approaches have been tested, with positive results.
A transoral or endoluminal approach (i.e. a procedure that requires no incision, because access is granted through the mouth) offers the potential for additional benefit to the patient, because the procedures continue to become more and more minimally invasive.
Advances in endoluminal devices are now allowing clinicians the ability to begin exploring bariatric procedures performed via flexible endoscopy. Although these procedures may not be as effective as their surgical counterparts, these less-invasive options may relieve patients of the significant risks associated with surgery and might become part of the armamentarium of obesity management.
Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is a CE marked device that may be attached to an endoscope inside the body and allows remote actuation of the device during a peroral intervention. It offers the possibilities of making transoral full thickness tissue apposition and may allow performing, via a transoral route, large plications with tight serosa to serosa apposition.
After a first trial on pigs (safety), a second trial on human patients was performed. This trial included 11 patients treated with the same technique. There were no complications and the short term results were encouraging with 41% EWL at 6 month.
A multicentric trial NCT02582229 entitled: " A Prospective Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Gastric Reduction. " is ongoing and inclusion of patients ended in December 2016 with a total of 51 patients included in 3 European centers. Early results of the trial had showed that dietician follow-up is an important part of the success. During that time implementation of the procedure had been done.
The aim of this trial is to compare a control group (diet alone) with a treatment group (Endomina procedure plus diet).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment group
Endoscopic sleeve gastroplasty (Endomina) at J0 with multidisciplinary follow-up for 1 year
Endomina
Endoscopic sleeve reduction
Controled group
Diet for 6 months then Endoscopic sleeve gastroplasty (Endomina) with multidisciplinary follow-up for 1 year
Endomina
Endoscopic sleeve reduction
Diet
Multidisciplinary follow-up
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Endomina
Endoscopic sleeve reduction
Diet
Multidisciplinary follow-up
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Class I or class II obesity (i.e. BMI between 30 to 40 kg/m²);
3. Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment, endoscopy, radiography, as well as laboratory investigations;
4. Must be able to understand and be willing to provide written informed consent;
5. Must live within 75 km of the treatment site;
6. Had followed the bariatric multidisciplinary workup (blood analyses, dietician, psychologist and doctor appointments).
Exclusion Criteria
2. Severe esophagitis;
3. Gastro-duodenal ulcer;
4. Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
5. Hypertension: uncontrolled hypertension during last 3 months;
6. Diabetes: uncontrolled diabetes (on insulin therapy or oral therapy with Hba1c \> 10%);
7. TBWL \>5% over the last 6 months;
8. Severe renal, hepatic, pulmonary disease or cancer;
9. GI stenosis or obstruction;
10. Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months;
11. Previous bariatric surgery, balloon or other endoscopic obesity-related therapy;
12. Anticoagulant therapy;
13. Impending gastric surgery 60 days post intervention;
14. Currently participating in other study
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Erasme University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gastroenterology Department Erasme Hospital
Brussels, , Belgium
APHM Hopital Marseille Nord Hepato-Gastroentérologie et Oncologie Digestive
Marseille, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
ASGE Bariatric Endoscopy Task Force and ASGE Technology Committee; Abu Dayyeh BK, Kumar N, Edmundowicz SA, Jonnalagadda S, Larsen M, Sullivan S, Thompson CC, Banerjee S. ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc. 2015 Sep;82(3):425-38.e5. doi: 10.1016/j.gie.2015.03.1964. Epub 2015 Jul 29.
Magro DO, Geloneze B, Delfini R, Pareja BC, Callejas F, Pareja JC. Long-term weight regain after gastric bypass: a 5-year prospective study. Obes Surg. 2008 Jun;18(6):648-51. doi: 10.1007/s11695-007-9265-1. Epub 2008 Apr 8.
Menchaca HJ, Harris JL, Thompson SE, Mootoo M, Michalek VN, Buchwald H. Gastric plication: preclinical study of durability of serosa-to-serosa apposition. Surg Obes Relat Dis. 2011 Jan-Feb;7(1):8-14. doi: 10.1016/j.soard.2010.11.002. Epub 2010 Nov 12.
Fogel R, De Fogel J, Bonilla Y, De La Fuente R. Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients. Gastrointest Endosc. 2008 Jul;68(1):51-8. doi: 10.1016/j.gie.2007.10.061. Epub 2008 Mar 19.
Paxton JH, Matthews JB. The cost effectiveness of laparoscopic versus open gastric bypass surgery. Obes Surg. 2005 Jan;15(1):24-34. doi: 10.1381/0960892052993477.
Huberty V, Ibrahim M, Hiernaux M, Chau A, Dugardeyn S, Deviere J. Safety and feasibility of an endoluminal-suturing device for endoscopic gastric reduction (with video). Gastrointest Endosc. 2017 Apr;85(4):833-837. doi: 10.1016/j.gie.2016.08.007. Epub 2016 Aug 22.
ASGE Bariatric Endoscopy Task Force; ASGE Technology Committee; Abu Dayyeh BK, Edmundowicz SA, Jonnalagadda S, Kumar N, Larsen M, Sullivan S, Thompson CC, Banerjee S. Endoscopic bariatric therapies. Gastrointest Endosc. 2015 May;81(5):1073-86. doi: 10.1016/j.gie.2015.02.023. Epub 2015 Mar 28. No abstract available.
ASGE/ASMBS Task Force on Endoscopic Bariatric Therapy; Ginsberg GG, Chand B, Cote GA, Dallal RM, Edmundowicz SA, Nguyen NT, Pryor A, Thompson CC. A pathway to endoscopic bariatric therapies. Gastrointest Endosc. 2011 Nov;74(5):943-53. doi: 10.1016/j.gie.2011.08.053. No abstract available.
Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
Huberty V, Boskoski I, Bove V, Van Ouytsel P, Costamagna G, Barthet MA, Deviere J. Endoscopic sutured gastroplasty in addition to lifestyle modification: short-term efficacy in a controlled randomised trial. Gut. 2020 Oct 28:gutjnl-2020-322026. doi: 10.1136/gutjnl-2020-322026. Online ahead of print.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P2017/401
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.