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

NCT02582229 | Completed

• 1 other identifier: P2015/432
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 3

Brief Summary

Surgery is 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 later 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 (1,2). 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 (3,4). A transoral or endoluminal approach (ie, 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 (5).

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• Weight Loss

  Weight loss - Excess Weight Loss - BMI

  one year

Secondary Outcomes (1)

• Complications

  one year

Study Arms (1)

Interventionnal

EXPERIMENTAL

The intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of 4-6 transmural anterior-posterior sutures after argon plasma coagulation of the tissue opposition areas in order to ensure persistence of the pouch reduction. Patient will be kept overnight after the procedure.

Device: Endomina

Interventions

Endomina DEVICE

The intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of 4-6 transmural anterior-posterior sutures after argon plasma coagulation of the tissue opposition areas in order to ensure persistence of the pouch reduction. Patient will be kept overnight after the procedure.

Interventionnal

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 21-64 years;
• BMI between 30 to 40 kg/m²
• 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.
• Must be able to understand and be willing to provide written informed consent.

You may not qualify if:

• Achalasia and any other esophageal motility disorders
• 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.
• Hypertension: uncontrolled hypertension during last 3 month
• Severe renal, hepatic, pulmonary disease or cancer;
• GI stenosis or obstruction
• Pregnancy or breastfeeding
• Impending gastric surgery 60 days post intervention;
• Currently participating in other study

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (3)

Gastroenterology Department Erasme Hospital

Brussels, 1070, Belgium

Location

Internal cilic - department of Gastroenterology - University Hospital

Ostrava, 70800, Czechia

Location

U.O. Endoscopia Digestiva Chirurgica

Roma, 00168, Italy

Location

Related Publications (5)

• 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.

  PMID: 15479938 RESULT

• 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.

  PMID: 18392907 RESULT

• 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.

  PMID: 18355825 RESULT

• 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.

  PMID: 15760496 RESULT

• Huberty V, Machytka E, Boskoski I, Barea M, Costamagna G, Deviere J. Endoscopic gastric reduction with an endoluminal suturing device: a multicenter prospective trial with 1-year follow-up. Endoscopy. 2018 Dec;50(12):1156-1162. doi: 10.1055/a-0630-1224. Epub 2018 Jun 15.

  PMID: 29906810 DERIVED

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacques Deviere, MD,PhD

  Hopital Erasme, Gastroenterology Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 21, 2015
• Study Start: November 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 13, 2016

Record last verified: 2016-09

Locations

CZ (1); BE (1); IT (1)