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Clinical Trial for Weight Regain Post-RYGB: APC Versus APC Plus Endoscopic Suture Technique

NCT03094936 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-03-29

No results posted yet for this study

Summary

Obesity is a worldwide health and sociopolitical problem. Excessive body-weight currently affects over 50% of the Brazilian population. It has been well established that obesity is an independent health risk. Obese individuals are at increased to extremely high risk for many diseases and for early death relative to those with normal weights and waist circumferences. The increased disease susceptibility for this subset of patients includes hypertension, stroke, hyperlipidemia, sleep apnea, Type 2 diabetes, neoplasms, Gastro-Esophageal Reflux Disease, and musculoskeletal disorders.

Bariatric surgery is the most effective treatment for obesity. As bariatrics grow, the number of patients suffering from surgical-related complications also grows. One of the most worrisome long-term complications is weight regain, once the patient may be again affected by overweight-related comorbidities and face again pre-operative esthetic issues.

This trial focus on testing efficacy and safety of two endoscopic revisional procedures in patients suffering from weight regain following Roux-en-Y Gastric Bypass: Ablation with Argon Plasma Coagulation (APC) versus APC plus Endoscopic Full-thickness Suture (with Apollo Overstitch device). Pouch volume, gastric emptying and gut hormones changes will also be assessed.

Conditions

Interventions

PROCEDURE

APC

Ablation of the dilated gastro-jejunal anastomosis with Argon Plasma Coagulation. This procedure induces cicatrization process around the stoma and propitiates its reduction.

DEVICE

Endoscopic Suture Technique (OverStitch TM)

OverStitchTM Endoscopic Suturing System. Stitches will be placed per-orally with the aforementioned device around the dilated stoma in order to reduce the diameter of the anastomosis. In this group, ablation with APC will be done immediately before suturing.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Vitor O Brunaldi, MD · University of Sao Paulo General Hospital

  • Eduardo G Hourneaux de Moura, PhD · University of Sao Paulo General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-30
Primary Completion
2018-09-30
Completion
2018-10-31
FDA Device
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03094936 on ClinicalTrials.gov