NCT02231970

Brief Summary

Emerging endoscopic techniques are minimally invasive and can mimic the anatomic alterations achieved by surgical sleeve gastrectomy. The study hypothesis is if endoscopic sleeve gastroplasty is effective and useful in the treatment of patients with obesity

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 5, 2014

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

September 1, 2014

Last Update Submit

September 4, 2014

Conditions

Obesity

Keywords

ObesityEndoscopic sleeve gastroplastyWeight loss

Outcome Measures

Primary Outcomes (1)

  • Change in body weight

    One year

Secondary Outcomes (1)

  • Safety

    One year

Other Outcomes (1)

  • Percentage of excess weight loss

    One year

Study Arms (1)

Endoscopic sleeve gastroplasty

EXPERIMENTAL

The intervention is an endoscopic procedure: to perform endoscopic sleeve gastroplasty we used a cap-based flexible endoscopic suturing system (OverStitch™, Apollo, Inc. Austin, Texas) mounted on a double-channel endoscope (GIF-2T160; Olympus Medical Systems Corporation, Tokyo, Japan) to achieve full-thickness, running sutures through the gastric wall from antrum to fundus.

Procedure: Endoscopic sleeve gastroplasty

Interventions

Endoscopic sleeve gastroplastyPROCEDURE

To perform endoluminal gastric volume reduction by the Endoscopic sleeve gastroplasty

Also known as: ESG
Endoscopic sleeve gastroplasty

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Obesity Willingness and ability of patients to be treated by a multidisciplinary team for at least 1 year -

You may not qualify if:

  • Prior endoscopy discarded patients with gastric findings (potentially bleeding lesions and neoformative findings ) Coagulopathy Psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Sanchinarro

Madrid, Madrid, 28050, Spain

RECRUITING

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • GONTRAND LOPEZ-NAVA, MD

    HOSPITAL UNIVERSITARIO SANCHINARRO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GONTRAND LOPEZ-NAVA, MD

CONTACT

+34917567800gontrandlopeznava@gmail.com

INMACULADA BAUTISTA-CASTAÑO, MD, PHD

CONTACT

+34917567800inmaculadabautista60@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Clinical Trial Unit

Study Record Dates

First Submitted

September 1, 2014

First Posted

September 4, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2016

Last Updated

September 5, 2014

Record last verified: 2014-09

Locations

ES(1)