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Bariatric Endoscopy for Treatment of Obesity

ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMater Olbia Hospital

About this trial

A single-center, randomized trial will be conducted in order to compare three Endoscopic Gastroplasty (EG) techniques in obese patients (BMI 30-44.99 kg/m2) at Gastroenterology and Gastrointestinal Endoscopy Unit, Mater Olbia Hospital, Qatar Foundation Endowment \& Gemelli Foundation, Italy in period June 2020 - August 2024, with the aim to compare the efficacy and safety of these procedures.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age > 18 years old;

acceptance of written informed consent to undergo an EG;

capability to understand and comply with the study protocol;

obesity: a BMI of 30-34.99 kg/m2 with previous failed attempts at diet and with obesity-related diseases, a BMI of 35-39.99 kg/m2 with previous failed attempts at diet and with or without obesity-related diseases, a BMI of 40-44.99 kg/m2 with previous failed attempts at diet and with or without obesity-related diseases not fit for surgery.

Disqualifiers

patients who do not give their consent to the enrollment in the study or are incompetent, unconscious or unable to express their consent for any reason;

patients suffering from any condition which precludes compliance with study instructions;

patients who underwent previous attempts at surgical or endoscopic bariatric therapy;

patient has any allergy or other known contraindication or intolerance to the medications used in the study;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endoscopic gastroplasty

    Procedure/Surgery

    Endoscopic Gastroplasty

Treatment groups

189 Participants
are divided into 3 treatment groups
Group A: Patients undergoing Endoscopic Sleeve GastroplastyActive comparator 1 intervention
Group B: Patients undergoing Endoluminal Vertical GastroplastyActive comparator 1 intervention
Group C: Patients undergoing Primary Obesity Surgical Endolumenal 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Total Body Weight Loss (TBWL percent)

To evaluate the percentage of Total Body Weight Loss after each endoscopic bariatric procedure

Time frame
at 30±15, 90±30, 180±30, 360±30, 540±30 days after the procedure

Secondary outcomes

1

Percentage of Excess Weight Loss (EWL percent)

To evaluate the percentage of Excess Weight Loss after each endoscopic bariatric procedure

Time frame
at 30±15, 90±30, 180±30, 360±30, 540±30 days after the procedure
2

Safety in terms of occurrance intra-procedural, post-procedural and late adverse events (AEs).

bleeding (YES/NO), perforation (YES/NO), fistula (YES/NO)

Time frame
intra-procedural, up to 14 days and any time after 14 days
3

Technical success rate

percentage of procedures completed without abortion

Time frame
intra-procedural
4

Pain procedure-related

NRS pain scale (0-10 points, where 0 is no pain and 10 is the worst pain imaginable)

Time frame
the day before the procedure, at 12, 24 hours after the procedure

Other outcomes

Sponsors and contacts

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

Mater Olbia Hospital

Lead sponsor

Source ClinicalTrials.gov
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