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COMPLETED

NCT07647991

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

Sponsor: Medical University of Vienna

View on ClinicalTrials.gov

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.

Official title: Intra-gastric Balloon (IGBalloon(R)) for Use in the Treatment of Obesity - a Pilot Study

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-03-01

Completion Date

2024-07-15

Last Updated

2026-06-15

Healthy Volunteers

Conditions

Weight Loss Adverse Events Comorbidities

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.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Life expectancy of less than 2 years. * Participation in another clinical trial investigating a therapeutic device or medicine. * Major prior or present psychological or psychiatric disorder (including a history of drug and/or alcohol addiction, severe depression, Electroconvulsive Therapy (ECT) treatment - current or recent.) * Inability to tolerate blood draws. * Inability or unwillingness to swallow large items after coaching in swallowing technique. * If female, lactating or positive pregnancy test at screening or before each of the treatment periods. * If female and of child-bearing potential, unwillingness to abstain from sexual intercourse or use a medically acceptable method of contraception from 14 days before the study and throughout the entire study period. Acceptable methods of contraception: 1. Hormonal contraceptive, if used for at least 3 months prior to study. 2. Intrauterine device (IUD). 3. Condom and spermicide. 4. Diaphragm and spermicide. 5. Abstinence. 6. Surgical sterilization of either partner. * Previously defined non-compliance with prescribed medical care. * Identified eating disorder likely to significantly increase risk of complication. * Prior enrolment in this study.

Locations (1)

Medical University of Vienna

Vienna, State of Vienna, Austria