Health TrialsbyHealthPanel

Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss

ConditionsObesityObesity, MorbidMetabolic DiseaseWeight, Body
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrigham and Women's Hospital

About this trial

The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare "belt" with "belt and suspenders" plication pattern using the Endomina system to determine percent total weight loss.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with 18-65 years of age

BMI ≥ 30 kg/m2

Capable of giving informed consent and available to return for follow-up visit

Disqualifiers

Untreated H. pylori infection

Active gastric or duodenal ulceration

Malignant or premalignant gastric diseases (such as intestinal metaplasia, high grade dysplasia, gastric adenocarcinoma, or gastrointestinal stromal tumor (GIST))

Severe reflux esophagitis (Los Angeles Classification (LA) Grade C or D)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endoscopic Sleeve Gastroplasty - Belt and Suspenders

    Device

    Endoscopic sleeve gastroplasty using belt and suspender plications.

  • Endoscopic Sleeve Gastroplasty - Belt

    Device

    Endoscopic sleeve gastroplasty using belt only plications.

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Belt and Suspenders ConfigurationActive comparator 1 intervention
Group B: Belt ConfigurationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent TWL (%TWL)

Change in the percent total weight loss from baseline at 6 and 12 months.

Time frame
Baseline, 6 months, 12 months
2

Adverse Events

Presence of adverse events that develop post-procedure

Time frame
6 months, 12 months

Secondary outcomes

1

Gastric Emptying

Comparison of gastric emptying rate using Gastric Emptying Breath Test (GEBT) from baseline to 6 months and 12 months post-procedure

Time frame
Baseline, 6 month, 12 months
2

Number of participants with improvement in fasting glucose

Change in fasting glucose laboratory values from baseline at 6 and 12 months post-procedure

Time frame
Baseline, 6 months, 12 months
3

Number of participants with improvement in Hemoglobin A1c (HgA1c %)

Change in HgA1c laboratory values from baseline at 6 and 12 months post-procedure

Time frame
Baseline, 6 months, 12 months
4

Improvement in fasting lipids profile

Change in fasting lipids laboratory values from baseline at 6 and 12 months post-procedure

Time frame
Baseline, 6 months, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Endo Tools Therapeutics S.A.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: