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The IGBallon (R) - for Use in the Treatment of Obesity

NCT07647991 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-06-15

No results posted yet for this study

Summary

This study is a prospective, non-randomized, open-label, single-center study.

The aim of this study is to assess the safety of the IGballoon in the human body. The effectiveness of the IGBalloon in relation to weight loss behaviour of the human body will also be investigated. This study will involve 20 participants who will be divided into two groups:

1. Monitoring group with 5 participants who swallow an IGBalloon. After four weeks, safety will be tested. Up to four additional IGBalloons may be ingested, if necessary, over the following eight weeks.
2. Treatment group of 15 participants receiving up to 5 IGBalloons over a period of 8 weeks as required. This group will be evaluated for efficiency of the IGBalloon.

Various examinations, such as clinical examinations, blood tests, and gastroscopies will be carried out at certain follow-up points. Patients also receive dietary support for the entire duration of the study.

Conditions

Interventions

DEVICE

IGBalloon

An initial five participants meeting eligibility requirements will ingest one IGBalloon(IGB), undergo an immediate endoscopy to assess device inflation and condition of the gastric mucosa and will be followed-up at 1, 2, 4, 6 and 8 weeks. At the 2-week follow-up, a second IGB is ingested in the event that there is no decrease in weight or increase in satiety. After 4-weeks, an additional IGB is ingested in the event that there is no decrease in weight and increase in satiety. After 6-weeks, an additional IGB may be ingested in the event that there is no decrease in weight and increase in satiety. After 8-weeks, an additional device (max. of 5) may be ingested in the event that there is no decrease in weight and increase in satiety. The initial 5 sentinel patients will undergo a controlendoscopy. No more than five IGB are ingested. If no significant changes or unanticipated SAEs have occurred in the initial five participants, a further 15 participants will begin the treatment.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Gerhard Prager, Univ. Prof. · Medical University of Vienna

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-07-15
Completion
2024-07-15

Countries

  • Austria

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 NCT07647991 on ClinicalTrials.gov