Overweight and ObesityNCT04800835
A Study to Compare the 12-month Spatz3 Adjustable Balloon With a 6-month Non Adjustable Balloon
A study testing Gastric Balloon in people with Overweight and Obesity, run by Spatz FGIA, Inc at 1 site in Czechia.
Trial summary
The purpose of this study is to compare a 12-month adjustable balloon over a 6-month non-adjustable balloon with 6-month dietician follow-up. The endpoint is %TBL at 12 months. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Gastric Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Feb 2021to 10 Jul 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a BMI ≥ 27
- Be male or female, between 18 and 65 years of age, inclusive;
- Have a history of excess weight (BMI ≥ 27 kg/m2) for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavioral modification programs;
- Be willing to commit to a long-term low calorie (1000-1500 calories/day) supervised diet;
- Have reasonable weight loss expectations (accept a goal of losing up to 15% of body weight after 52 weeks);
- Be able to follow requirements outlined in the protocol, including complying with the visit schedule and behavioral modification program, and willing to undergo protocol-specific procedures, e.g., endoscopy, local sedation, general anesthesia, upper gastrointestinal radiography (UGI), electrocardiography (EKG), gastric motility testing, and/or clinical laboratory testing, and must be willing to take prescribed proton pump inhibitors (PPIs);
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- Be able to provide written informed consent;
- supporting that the subject is an appropriate study candidate;
- Be willing to use contraception (e.g., birth control pills, condoms, abstinence) and avoid pregnancy during the study if female of child-bearing potential.
Who cannot join
- Previous history of esophageal, gastric or duodenal surgery, any bariatric surgery, any hiatal hernia surgery, bowel obstruction surgery, adhesive peritonitis, and/or hiatal hernia > 4 cm;
- A history of myocardial infarction in the previous 6 months: New York Heart Associate (NYHA) Class III or IV (heart failure) or cardiac arrhythmia (e.g. atrial fibrillation);
- History or symptoms of varices, bowel obstruction, congenital or acquired GI anomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal, hepatic, and/or pulmonary disease;
- History or symptoms of inflammatory bowel disease, such as Crohn's disease;
- History of unstable thyroid disease;
- History of uncontrolled gastro-esophageal reflux;
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- Type I diabetes;
- History of dysphagia, esophageal stricture or esophageal food impaction;
- Poor general health, in the opinion of the Placing and/or Evaluating Investigator, or presence of a specific medical condition that would increase the risks associated with endoscopy and/or placement of the device;
- Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
- Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD);
- Specific diagnosed genetic or hormonal cause for obesity such as Prader Willi syndrome;
- History or symptoms of esophageal or GI motility disorders (e.g., gastroparesis, achalasia, diffuse esophageal spasm) or symptoms of esophageal stricture;
- Ongoing treatment with anticoagulants, steroids, aspirin > 100 mg, non-steroidal anti- inflammatory drugs (NSAIDS), or other medications known to be gastric irritants, and inability or unwillingness to discontinue the use of these concomitant medications;
- Evidence of untreated psychiatric or eating disorders, such as major depression, schizophrenia, substance abuse;
- Pregnancy, breast-feeding, or intention of becoming pregnant during the study (if female of childbearing potential);
- A condition, or is in a situation, which in the Evaluating and/or Placing Investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Asclepiades - interna a gastroenterologie, s.r.o.
Havířov, 736 01
About this study
Official title: A Study to Compare the Safety and Effectiveness of the 12-month Spatz3 Adjustable Balloon With a 6-Month Non Adjustable Balloon in the Weight Management of Subjects
The purpose of this study is to compare a 12-month adjustable balloon over a 6-month non-adjustable balloon with 6-month dietician follow-up. The endpoint is %TBL at 12 months.
Read the detailed description
Subjects will be studied in a randomized open label single center study that will run 52 weeks. Subjects will be randomized to two treatment groups: Group 1- Spatz3 adjustable balloon 12-month implantation; and Group 2 - non adjustable 6-month implantation with additional 6 months of dietician follow-up after balloon extraction. Fourth four eligible subjects will be randomized to treatment groups 1 and 2 and will undergo endoscopy and implantation of either the Spatz3 Adjustable Balloon or the 6-month non adjustable Balloon. All subjects will follow a calorie restricted diet designed by the dietician. The initial diet will be liquid and will be advanced as per the dietician's recommendations. Changes in diet will depend on subject tolerance to the balloon and specific food intolerances and will be adjusted frequently by the dietician. The initial balloon volume will be 500 ml of 0.9% normal saline with 2 ml of a 1% solution of methylene blue. An adjustment will be performed for treatment Group 1 at Week 24 (±6 weeks) with the addition of 200-300 ml of 0.9% normal saline, as per section 1.6.2.1.3.3. The balloon adjustment procedure is done with an endoscopy procedure under the same sedation as the implantation procedure. The subjects will have follow up by the PI/Nurse Practitioner and the Dietician/Nutritionist periodically as per section 1.7.3. until extraction at 52 weeks. The 6-month non adjustable balloon treatment group will undergo balloon extraction at 6 months followed by monthly dietician vists for an additional 6 months. The study will terminate at the end of 12 months.
- Conditions
- Overweight and Obesity
- Being tested
- Gastric Balloon
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric BalloonDevice
implantation of two types of gastric balloons. Spatz3 Adjustable balloon will be implanted for 12 months and 6-month non adjustable balloon will be implanted for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1- Spatz3 adjustable balloon 12-month implantation; | Active comparator | A 12 month adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed Receives: Device: Gastric Balloon |
| Group 2- 6-month non adjustable balloon implantation with additional 6 months follow-up | Active comparator | A 6-month non adjustable intragastric balloon for weight loss Receives: Device: Gastric Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in total body weight (%TBL) .
Percent change in total body weight (%TBL) .
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start15 Feb 2021
- Primary completion10 Jul 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be studied in a randomized open label single center study that will run 52 weeks. Subjects will be randomized to two treatment groups: Group 1- Spatz3 adjustable balloon 12-month implantation; and Group 2 - 6-month non adjustable balloon implantation with additional 6 months of dietician follow-up after balloon extraction
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spatz FGIA, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evžen Machytka, MD, PhD, Principal investigator, Asclepiades - Interna a Gastroenterologie, s.r.o.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800835
- Sponsor's protocol ID
- Sp12Or6
- Status last verified
- Jul 2022
- First submitted
- 10 Mar 2021
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The authors have no plan make individual participant data available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare the Safety and Effectiveness of the 12-month Spatz3 Adjustable Balloon With a 6-Month Non Adjustable Balloon in the Weight Management of Subjects
- ClinicalTrials.gov ID
- NCT04800835
- Acronym / sponsor ID
- Sp12Or6
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Spatz FGIA, IncUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 16 Mar 2021 (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.
The purpose of this study is to compare a 12-month adjustable balloon over a 6-month non-adjustable balloon with 6-month dietician follow-up. The endpoint is %TBL at 12 months.
Detailed description
Subjects will be studied in a randomized open label single center study that will run 52 weeks. Subjects will be randomized to two treatment groups: Group 1- Spatz3 adjustable balloon 12-month implantation; and Group 2 - non adjustable 6-month implantation with additional 6 months of dietician follow-up after balloon extraction. Fourth four eligible subjects will be randomized to treatment groups 1 and 2 and will undergo endoscopy and implantation of either the Spatz3 Adjustable Balloon or the 6-month non adjustable Balloon. All subjects will follow a calorie restricted diet designed by the dietician. The initial diet will be liquid and will be advanced as per the dietician's recommendations. Changes in diet will depend on subject tolerance to the balloon and specific food intolerances and will be adjusted frequently by the dietician. The initial balloon volume will be 500 ml of 0.9% normal saline with 2 ml of a 1% solution of methylene blue. An adjustment will be performed for treatment Group 1 at Week 24 (±6 weeks) with the addition of 200-300 ml of 0.9% normal saline, as per section 1.6.2.1.3.3. The balloon adjustment procedure is done with an endoscopy procedure under the same sedation as the implantation procedure. The subjects will have follow up by the PI/Nurse Practitioner and the Dietician/Nutritionist periodically as per section 1.7.3. until extraction at 52 weeks. The 6-month non adjustable balloon treatment group will undergo balloon extraction at 6 months followed by monthly dietician vists for an additional 6 months. The study will terminate at the end of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subjects will be studied in a randomized open label single center study that will run 52 weeks. Subjects will be randomized to two treatment groups: Group 1- Spatz3 adjustable balloon 12-month implantation; and Group 2 - 6-month non adjustable balloon implantation with additional 6 months of dietician follow-up after balloon extraction
| Arm | Type | Receives |
|---|---|---|
| Group 1- Spatz3 adjustable balloon 12-month implantation; | Active comparator | Device: Gastric BalloonA 12 month adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed |
| Group 2- 6-month non adjustable balloon implantation with additional 6 months follow-up | Active comparator | Device: Gastric BalloonA 6-month non adjustable intragastric balloon for weight loss |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have a BMI ≥ 27
- Be male or female, between 18 and 65 years of age, inclusive;
- Have a history of excess weight (BMI ≥ 27 kg/m2) for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavioral modification programs;
- Be willing to commit to a long-term low calorie (1000-1500 calories/day) supervised diet;
- Have reasonable weight loss expectations (accept a goal of losing up to 15% of body weight after 52 weeks);
Key exclusion criteria (17 listed)
- Previous history of esophageal, gastric or duodenal surgery, any bariatric surgery, any hiatal hernia surgery, bowel obstruction surgery, adhesive peritonitis, and/or hiatal hernia > 4 cm;
- A history of myocardial infarction in the previous 6 months: New York Heart Associate (NYHA) Class III or IV (heart failure) or cardiac arrhythmia (e.g. atrial fibrillation);
- History or symptoms of varices, bowel obstruction, congenital or acquired GI anomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal, hepatic, and/or pulmonary disease;
- History or symptoms of inflammatory bowel disease, such as Crohn's disease;
- History of unstable thyroid disease;
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 |
|---|---|---|
| Gastric Balloonimplantation of two types of gastric balloons. Spatz3 Adjustable balloon will be implanted for 12 months and 6-month non adjustable balloon will be implanted for 6 months | Device | Group 1- Spatz3 adjustable balloon 12-month implantation;, Group 2- 6-month non adjustable balloon implantation with additional 6 months follow-up |
Primary outcome
Percent change in total body weight (%TBL) .
Time frame: 12 months
Percent change in total body weight (%TBL) .
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 28 Nov 2022.
- Individual participant dataSharing planned: No. The authors have no plan make individual participant data available to other researchers
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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.
Evžen Machytka, MD, PhD principal investigator
Asclepiades - Interna a Gastroenterologie, s.r.o.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric Balloon in people with Overweight and Obesity, run by Spatz FGIA, Inc at 1 site in Czechia.
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 9 inclusion and 17 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 28 Nov 2022. 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 Czechia. 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?
Percent change in total body weight (%TBL) . (time frame: 12 months). 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 28 Nov 2022.