Suspended

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

What is being tested

Elipse Intragastric Balloon

Device

Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 18 to 64 Years

+41 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: August 2014

See protocol details

Summary

Principal SponsorAllurion Technologies

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2014

Actual date on which the first participant was enrolled.

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.

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

NCT02802007

Principal SponsorAllurion Technologies

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

42 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 64 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

15 inclusion criteria required to participate

Females must be willing to use contraception throughout the course of the trial until they exit.

Patient, female or male, 18 to 64 years of age.

Patient must be able to understand and be willing to sign an IC document.

Patient must be willing to participate in all aspects of the trial for the duration of the trial.

Show More Criteria

26 exclusion criteria prevent from participating

Patient has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.

Patient has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.

Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to surgery), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.

Patient has had previous bariatric or gastric surgery.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Patients seeking weight loss received the Elipse Intragastric Balloon.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Ostrava University Hospital

Ostrava, CzechiaOpen Ostrava University Hospital in Google Maps

Suspended

Iatriko Palaiou Faliro

Athens, Greece

Suspended2 Study Centers