Weight LossIGBallonNCT07647991
The IGBallon (R) - for Use in the Treatment of Obesity
A study testing IGBalloon in people with Weight Loss and Adverse Events, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Weight Loss, Adverse Events, Comorbidities
- What is being tested?
- IGBalloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2024to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 32Show fewer
- 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:
- Hormonal contraceptive, if used for at least 3 months prior to study.
- Intrauterine device (IUD).
- Condom and spermicide.
- Diaphragm and spermicide.
- Abstinence.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-gastric Balloon (IGBalloon(R)) for Use in the Treatment of Obesity - a Pilot Study
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:
Read more
- 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.
- 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.
Read the detailed description
The study will be divided into a screening phase and treatment period. Informed consent must be obtained prior to conducting any screening or other study-related procedures or evaluations.
The screening phase will take place 28 days prior to the administration/ingestion of the first device. Participants will be evaluated against the protocol-specific inclusion and exclusion criteria to determine their eligibility for participation in the study. An initial five (5) participants meeting eligibility requirements will ingest a single IGBalloon, undergo an immediate endoscopy to assess device inflation and initial condition of the gastric mucosa and will be followed-up at 1, 2, 4, 6, and 8 weeks.
At the 2 week follow-up appointment, a second IGBalloon may be ingested if there is no decrease in weight and/or increase in satiety.
At the 4 week follow-up appointment, again, an additional IGBalloon may be ingested if there is no decrease in weight and/or increase in satiety.
At the 6 week follow-up appointment, an additional IGBalloon may be ingested if there is still no decrease in weight and/or increase in satiety.
At the 8 week follow-up, an additional device (maximum of 5) for the same reasons mentioned above.
The initial 5 sentinel patients will undergo an endoscopy to observe balloon inflation and condition of the gastric mucosa. No more than five (5) IGBalloons may be ingested by a single participant. In the event that no significant changes have occurred to the gastric mucosa and no other unanticipated serious adverse events have occurred in the initial five participants, a further 15 participants will begin the treatment and follow-up regimen. This larger cohort of participants will not undergo the endoscopy procedure at the 8 week follow-up but follow the same treatment and follow-up regimen in all other aspects.
Further follow-up consultations will occur at 12, 16, 20, 24 and 36 weeks following the ingestion of the first IGBalloon. A final 52-week follow-up will include an additional endoscopy procedure on all participants. Following the 52 week follow-up of all participants, the study will be deemed to have been completed. Participants may elect to keep the IGBalloons in place, or have them removed at the 52 week endoscopy procedure. Those participants electing to keep the balloons in place will be monitored on an ongoing basis. Should participants require follow-up for adverse events or require any additional clinical laboratory or physical examinations, they may return to the clinic as deemed appropriate by the physician.
- Conditions
- Weight Loss, Adverse Events, Comorbidities
- Being tested
- IGBalloon
- Keywords
- Gastric Balloon, Swallowing Balloon, Obesity
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGBalloonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| IGBalloon treatment | Experimental | 20 patients Receives: Device: IGBalloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate (Clavien Dindo grade 3b) of the IGBalloon
Rate of re-operation in %
Measured: up to 52 weeks
Weight loss of the IGBalloon
Total weight loss in %
Measured: up to 52 weeks
Remission of comorbidities of the IGBalloon
Remission of comorbidities (art. Hyperention, DMII, obstructive sleep apnea) in %
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Mar 2024
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical testing of a medical device
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Prager, Medical University of Vienna
- Investigators
- Gerhard Prager, Univ. Prof., Study director, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647991
- Sponsor's protocol ID
- 1921/2022
- Acronym
- IGBallon
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Analysis will be performed on anonymized data only. A list cross-linking the patient number to the name will be kept secure and is only available to the principal researcher. Written informed consent will be kept for 15 years.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-gastric Balloon (IGBalloon(R)) for Use in the Treatment of Obesity - a Pilot Study
- ClinicalTrials.gov ID
- NCT07647991
- Acronym / sponsor ID
- IGBallon / 1921/2022
- Conditions
- Weight Loss, Adverse Events, Comorbidities
- Keywords
- Gastric Balloon, Swallowing Balloon, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Detailed description
The study will be divided into a screening phase and treatment period. Informed consent must be obtained prior to conducting any screening or other study-related procedures or evaluations.
The screening phase will take place 28 days prior to the administration/ingestion of the first device. Participants will be evaluated against the protocol-specific inclusion and exclusion criteria to determine their eligibility for participation in the study. An initial five (5) participants meeting eligibility requirements will ingest a single IGBalloon, undergo an immediate endoscopy to assess device inflation and initial condition of the gastric mucosa and will be followed-up at 1, 2, 4, 6, and 8 weeks.
At the 2 week follow-up appointment, a second IGBalloon may be ingested if there is no decrease in weight and/or increase in satiety.
At the 4 week follow-up appointment, again, an additional IGBalloon may be ingested if there is no decrease in weight and/or increase in satiety.
At the 6 week follow-up appointment, an additional IGBalloon may be ingested if there is still no decrease in weight and/or increase in satiety.
At the 8 week follow-up, an additional device (maximum of 5) for the same reasons mentioned above.
The initial 5 sentinel patients will undergo an endoscopy to observe balloon inflation and condition of the gastric mucosa. No more than five (5) IGBalloons may be ingested by a single participant. In the event that no significant changes have occurred to the gastric mucosa and no other unanticipated serious adverse events have occurred in the initial five participants, a further 15 participants will begin the treatment and follow-up regimen. This larger cohort of participants will not undergo the endoscopy procedure at the 8 week follow-up but follow the same treatment and follow-up regimen in all other aspects.
Further follow-up consultations will occur at 12, 16, 20, 24 and 36 weeks following the ingestion of the first IGBalloon. A final 52-week follow-up will include an additional endoscopy procedure on all participants. Following the 52 week follow-up of all participants, the study will be deemed to have been completed. Participants may elect to keep the IGBalloons in place, or have them removed at the 52 week endoscopy procedure. Those participants electing to keep the balloons in place will be monitored on an ongoing basis. Should participants require follow-up for adverse events or require any additional clinical laboratory or physical examinations, they may return to the clinic as deemed appropriate by the physician.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical testing of a medical device
| Arm | Type | Receives |
|---|---|---|
| IGBalloon treatment | Experimental | Device: IGBalloon20 patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGBalloonAn 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. | Device | IGBalloon treatment |
Primary outcome
Complication rate (Clavien Dindo grade 3b) of the IGBalloon
Time frame: up to 52 weeks
Rate of re-operation in %
Weight loss of the IGBalloon
Time frame: up to 52 weeks
Total weight loss in %
Remission of comorbidities of the IGBalloon
Time frame: up to 52 weeks
Remission of comorbidities (art. Hyperention, DMII, obstructive sleep apnea) in %
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Yes. Analysis will be performed on anonymized data only. A list cross-linking the patient number to the name will be kept secure and is only available to the principal researcher. Written informed consent will be kept for 15 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Prager, Univ. Prof. study director
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IGBalloon in people with Weight Loss and Adverse Events, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate (Clavien Dindo grade 3b) of the IGBalloon (time frame: up to 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.