Endomina Controlled Study

Obesity Clinical Trial

Official title:

A Controlled Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) as an Aid for Endoscopic Gastric Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03255005
• Other study ID #: P2017/401
• Status: Completed
• Phase: N/A
• Start date: September 5, 2017
• Est. completion date: March 26, 2020

Study information

• Verified date: May 2020
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this trial is to evaluate the efficacy of an endoluminal vertical gastroplasty (EVG) using an endoluminal-suturing device. Safety will also be characterized, in particular by the incidence of all Adverse Device Effects (ADEs). A secondary endpoint is to compare a delayed treatment control group (diet alone; crossover at 6 months) with a treatment group (EVG plus diet). Other secondary endpoints include improvements in other obesity measures.

Description:

Surgery is currently the only effective treatment for morbid obesity and can be divided into restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary pancreatic deviation and duodenal switch) or a combination of both (RYGBP).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 26, 2020
• Est. primary completion date: March 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age between 18-65 years;

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:

1. Achalasia and any other esophageal motility disorders;

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

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Endomina
Endoscopic sleeve reduction

Behavioral:
• Diet
Multidisciplinary follow-up

Locations

Country	Name	City	State
Belgium	Gastroenterology Department Erasme Hospital	Brussels
France	APHM Hopital Marseille Nord Hepato-Gastroentérologie et Oncologie Digestive	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Countries where clinical trial is conducted

Belgium,  France, 

References & Publications (9)

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 — View Citation

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: 10.101 — View Citation

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.2 — View Citation

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. Review. Erratum in: JAMA. 2005 Apr 13;293(14):1728. — View Citation

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 — View Citation

Huberty V, Ibrahim M, Hiernaux M, Chau A, Dugardeyn S, Devière 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 201 — View Citation

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. — View Citation

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. — View Citation

Paxton JH, Matthews JB. The cost effectiveness of laparoscopic versus open gastric bypass surgery. Obes Surg. 2005 Jan;15(1):24-34. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all Adverse Device Effects	Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants.	one year from procedure
Primary	Weight loss	total weight loss and excess weight loss	one year from procedure
Secondary	Weight loss at 6 months	comparison between diet and treatment group at 6 months	at 6 months after the procedure (treatment group)
Secondary	More than 15% weight loss	Proportion of patients in the Endomina Group with a loss of weight of more than 15%	one year from procedure
Secondary	Quality of life	SF36	one year from procedure
Secondary	TBWL	Mean % total body weight loss (%TBWL)	one year from procedure
Secondary	Weight and height	To calculate the body mass index (BMI)	one year from procedure