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

NCT07647991 | Completed DMC

• 1 other identifier: 1921/2022
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Weight Loss; Adverse Events; Comorbidities

Keywords

Gastric Balloon; Swallowing Balloon; Obesity

Outcome Measures

Primary Outcomes (3)

• Complication rate (Clavien Dindo grade 3b) of the IGBalloon

  Rate of re-operation in %

  up to 52 weeks

• Weight loss of the IGBalloon

  Total weight loss in %

  up to 52 weeks

• Remission of comorbidities of the IGBalloon

  Remission of comorbidities (art. Hyperention, DMII, obstructive sleep apnea) in %

  up to 52 weeks

Study Arms (1)

IGBalloon treatment

EXPERIMENTAL

20 patients

Device: IGBalloon

Interventions

IGBalloon DEVICE

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.

IGBalloon treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index (BMI) greater than 35 or greater than 30 with comorbidities (type 2 diabetes, dyslipidemia, hypertension, obstructive sleep apnea, osteoarthritis, or coronary heart disease).
• Male or female participants aged between 18-70 years and representative of the general population.
• Availability for the entire study period, and willingness to adhere to protocol requirements as evidenced by giving signed informed consent.
• Failure at previous attempts at weight loss through diet, exercise, and/or behavior modification.

You may not qualify if:

• Severely obese (BMI \> 45) or \>120 kg.
• Previous gastric surgery affecting the esophagus, stomach, or pylorus that would interfere with ingestion or placement of the IGBalloon.
• Debilitating comorbidities preventing surgery.
• Inflammatory disease of the gastrointestinal (GI) tract.
• Upper-GI bleeding conditions.
• History of gastrointestinal ulcers or bleeding.
• Existing gallbladder disease.
• Positive breath test for the presence of H. pylori infection.
• Gastro-esophageal reflux resistant to proton pump inhibitors.
• Previously diagnosed with Cushing's disease and/or hypothyroidism.
• Malignant disease.
• Likely to require abdominal surgery during the study period.
• Upper-GI abnormalities or anatomical variants likely to interfere with the study procedure.
• Symptomatic documented hiatal hernia.
• Insulin-dependent diabetes mellitus.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Weight Loss; Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Gerhard Prager, Univ. Prof.

  Medical University of Vienna

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr.

Model Details: Clinical testing of a medical device

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 15, 2026
• Study Start: March 1, 2024
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)