ORBERA365 Post-Marketing Clinical Follow-up Study

Obesity Clinical Trial

Official title: A Prospective, Multicenter, Open-label, Post-approval Study of the Safety and Effectiveness of ORBERA365 as a 12-month Adjunct to Weight Reduction for Obese Adults or Pre-surgical Weight Reduction for Obese or Super-obese Adults

Status Not yet recruiting

Clinical Trial Summary

A prospective, multicenter, open-label, post-approval study of the safety and effectiveness of ORBERA36 as a 12-month adjunct to weight reduction for obese adults (BMI ≥ 27 kg/m2 and BMI ≤ 50 kg/m2) or for pre-surgical weight reduction in obese and super-obese adults (BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities).

Clinical Trial Description

This is a prospective, multicenter, open label study of the safety and effectiveness of ORBERA365™ for use as an adjunct to behavioral modification for obese adults (BMI ≥ 27 kg/m2 and BMI ≤ 50 kg/m2) or for pre-surgical weight reduction in obese and super-obese adults (BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities). All study subjects will participate in a behavioral modification program for 52 weeks, which will include a low calorie diet as well as nutritional and behavior modification counseling. Subjects will have ORBERA365™ placed for up to 52 weeks.

Evaluations while on treatment will be performed at baseline (pre-placement), Day 0 (ORBERA365 placement) and during monthly clinic visits during the 1st 6 months of device therapy and at months 9 and ORBERA365 removal. All subjects will have a final study visit at 12 months, or study exit, whichever comes first. Device removal will occur at 52 unless removed early by subject request and/or physician recommendation. Reasons for early removal may include, but are not limited to, adverse events, subject dissatisfaction or achievement of weight loss goal. ;

Related Conditions & MeSH terms

• Obesity
• Overweight

• NCT number: NCT04362774
• Study type: Observational
• Source: Apollo Endosurgery, Inc.
• Contact: Jeanette E Ahrens, PhD
• Phone: +1 214 683 5864
• Email: jeanette@pivsolutions.com
• Status: Not yet recruiting
• Start date: July 2020
• Completion date: December 2022