NCT02948621

Brief Summary

The endoscopic sleeve gastroplasty allows stomach size reduction through an endoluminal suture approach without any incision. It could reduce the complications associated with current surgical techniques while obtaining the target gastric restriction, weight loss, comorbidities and quality of life improvement. The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

October 26, 2016

Last Update Submit

January 5, 2024

Conditions

Morbid Obesity

Keywords

Endoscopic sleeve gastroplastyExcess weight lossQuality of life

Outcome Measures

Primary Outcomes (3)

  • Weight loss

    7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure

  • Excess weight loss

    7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure

  • Body mass index variation

    7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure

Secondary Outcomes (4)

  • Procedure reproducibility

    7 days, 1 - 3 - 6 - 9 and 12 months after procedure

  • Comorbidities improvement

    7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure

  • Quality of life improvement

    3 - 12 - 18 and 24 months after procedure

  • Modification in the feeling of satiety

    1 - 3 - 6 - 12 - 18 and 24 months after procedure

Study Arms (1)

Endoscopic sleeve gastroplasty

Endoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device (Overstitch, Apollo Endosurgery, Austin, Tx. USA). Continuous stitches are placed to create a sleeve-shaped gastric path of 2 cm diameter to reduce stomach volume from the proximal antrum to the oeso-gastric junction.

Procedure: Endoscopic sleeve gastroplasty

Interventions

Endoscopic sleeve gastroplastyPROCEDURE

Endoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device (Overstitch, Apollo Endosurgery, Austin, Tx. USA). Continuous stitches are placed to create a sleeve-shaped gastric path of 2 cm diameter to reduce stomach volume from the proximal antrum to the oeso-gastric junction.

Endoscopic sleeve gastroplasty

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients over 18 years old requiring a treatment for morbid obesity.

You may qualify if:

  • Patient \> 18 years old and \< 60 years old
  • Patient with morbid obesity for at least 2 years
  • Patient who failed medical and diet treatment of obesity
  • Patient with no contraindication to anesthesia
  • Patient able to understand the study and to provide informed consent.

You may not qualify if:

  • Patient with inflammatory, tumoral or bad quality tissues at endoscopy
  • Patient with a history of gastro-intestinal inflammatory disease, stenosis or intestinal adhesions, kidney or liver failure, chronic pancreatic disease
  • Patient with a history and/or signs and/or symptoms of gastroduodenal ulcerous disease and/or progressive gastroduodenal ulcerous disease
  • Patient with an oesophageal pathology as Zenker's diverticulum, peptic oesophagitis stage 3-4, oesophageal stenosis, Barrett syndrome, oesophageal cancer, dysphagia, achalasia
  • Patient with previous bariatric, gastric or oesophageal surgery, intestinal obstruction, portal hypertension, gastro-intestinal tumors, oesophageal or gastric varices, gastroparesis
  • Patient with a severe coagulopathy (prothrombin time \> 3 seconds or thrombocytic count \< 50 000/mm3) or treated with heparin, coumadin, warfarin or any other anticoagulants and drugs preventing coagulation or platelet aggregation, except aspirin and nonsteroidal anti-inflammatory drugs
  • Pregnancy, breastfeeding or woman without contraception
  • Patient with a congestive heart failure, arrhythmia or unstable coronary heart disease
  • Patient using or having used diet drugs within the last 30 days or intending to use them during study follow-up
  • Patient under drug treatment within the last 3 months known to induce weight gain
  • Patient with eating disorders or uncontrolled, poorly controlled or suspected psychiatric disease
  • Patient in a poor condition according to investigator
  • Patient with significative weight loss between date of enrollment in the study and date of procedure
  • Patient with a systemic infection the day of procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg

Strasbourg, 67000, France

Location

Related Publications (5)

  • Lopez-Nava G, Galvao MP, da Bautista-Castano I, Jimenez A, De Grado T, Fernandez-Corbelle JP. Endoscopic sleeve gastroplasty for the treatment of obesity. Endoscopy. 2015 May;47(5):449-52. doi: 10.1055/s-0034-1390766. Epub 2014 Nov 7.

    PMID: 25380508BACKGROUND

  • Lopez-Nava G, Galvao MP, Bautista-Castano I, Jimenez-Banos A, Fernandez-Corbelle JP. Endoscopic Sleeve Gastroplasty: How I Do It? Obes Surg. 2015 Aug;25(8):1534-8. doi: 10.1007/s11695-015-1714-7.

    PMID: 26003549BACKGROUND

  • Lopez-Nava G, Galvao M, Bautista-Castano I, Fernandez-Corbelle JP, Trell M. Endoscopic sleeve gastroplasty with 1-year follow-up: factors predictive of success. Endosc Int Open. 2016 Feb;4(2):E222-7. doi: 10.1055/s-0041-110771. Epub 2016 Jan 15.

    PMID: 26878054BACKGROUND

  • Sharaiha RZ, Kedia P, Kumta N, DeFilippis EM, Gaidhane M, Shukla A, Aronne LJ, Kahaleh M. Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population. Endoscopy. 2015 Feb;47(2):164-6. doi: 10.1055/s-0034-1390773. Epub 2014 Nov 7.

    PMID: 25380510BACKGROUND

  • Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24.

    PMID: 23711556BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Silvana Perretta, MD, PhD

    Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg

    PRINCIPAL INVESTIGATOR

  • Michel Vix, MD

    Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2016

First Posted

October 28, 2016

Study Start

October 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2020

Last Updated

January 8, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)