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Pilot Trial of the Elipse™ Intragastric Balloon System for the Treatment of Overweight and Obese Individuals

NCT02802007 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2016-06-16

No results posted yet for this study

Summary

This is a prospective, non-randomized, open trial to be conducted in overweight and obese individuals. The primary objective is to evaluate the safety of the Elipse™ Intragastric Balloon System for the treatment of overweight and obese individuals. The secondary objective is to collect efficacy and device performance information to assist with future trial design and device iterations.

Conditions

Interventions

DEVICE

Elipse Intragastric Balloon

Sponsors & Collaborators

  • Allurion Technologies

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-07-31

Countries

  • Czechia
  • Greece

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 NCT02802007 on ClinicalTrials.gov