Endoscopic Gastroplasty for Treatment of Obesity: a Single Centre, Randomized Trial

Status: Recruiting

Location: See location...

Intervention Type: Procedure

Study Type: Interventional

Study Phase: Not Applicable

SUMMARY

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

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 70

Healthy Volunteers: f

View:

• 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.

Locations

Other Locations

Italy

Mater Olbia Hospital

RECRUITING

Olbia

Contact Information

Primary

Salvatore F. Vadalà di Prampero, MD, PhD

vadaladiprampero@gmail.com

00393492666795

Time Frame

Start Date: 2020-06-19

Estimated Completion Date: 2025-02

Participants

Target number of participants: 189

Treatments

Active_comparator: Patients undergoing Endoscopic Sleeve Gastroplasty

Obese patients with I, II, and III grade of obesity (BMI 30-44.99 kg/m2) and previous failed attempts of diet.

Active_comparator: Patients undergoing Endoluminal Vertical Gastroplasty

Obese patients with I, II, and III grade of obesity (BMI 30-44.99 kg/m2) and previous failed attempts of diet.

Active_comparator: Patients undergoing Primary Obesity Surgical Endolumenal 2

Obese patients with I, II, and III grade of obesity (BMI 30-44.99 kg/m2) and previous failed attempts of diet.

Related Therapeutic Areas

Obesity

Endoscopy

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Endoscopic Gastroplasty for Treatment of Obesity: a Single Centre, Randomized Trial

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