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ORBERA365 Post-Marketing Clinical Follow-up Study

NCT04362774 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2024-12-31

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

ORBERA365

Behavioral modification program in conjunction with endoscopic placement of a single ORBERA365 Intragastric Balloon, filled with saline to an inflation volume between 400cc and 700cc with 2mL of Methylene blue (10mg/mL)

Sponsors & Collaborators

  • Apollo Endosurgery, Inc.

    lead INDUSTRY

Principal Investigators

  • Jose L Naveira · Apollo Endosurgery, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-23
Primary Completion
2023-02-21
Completion
2023-10-10

Countries

  • Spain

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 NCT04362774 on ClinicalTrials.gov