Overweight and ObesityNCT05007964
A Multi-Center Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4)
A study testing Spatz4 Adjustable Balloon System in people with Overweight and Obesity, run by Spatz FGIA, Inc at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27. Up to 66 eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz4 balloon. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Spatz4 Adjustable Balloon System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Jun 2022to 29 Aug 2023
- 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
- Healthy volunteers accepted
- 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;
- Have successful completion of the pre-placement screening and educational programs 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 Spatz4;
- 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.
About this study
Official title: A Multi-Center Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4).
The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27.
Up to 66 eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz4 balloon. All subjects will follow a calorie restricted diet designed by the dietician. An up adjustment will be performed at 16 weeks (±2 weeks). The subjects will be followed for 2 weeks after the up adjustment procedure, after which the study ends. Subjects will be given the option to continue the implantation period until 52 weeks.
Read the detailed description
The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27.
Subjects will be studied in an open label multi-center center study that will have one endpoint at 20 weeks. Up to 66 eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz4 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 450 to 550 ml of 0.9% normal saline with 2 ml of a 1% solution of methylene blue. It is estimated, based on clinical studies, that approximately 10% of subjects will be intolerant in the first month and will require a down adjustment, wherein 150 ml of fluid will be removed from the balloon. An up adjustment will be performed at 16 weeks (±2 weeks) with the addition of 200-300 ml of 0.9% normal saline. The balloon adjustment procedure is done with an endoscopy procedure under the same sedation as the implantation procedure.
The subjects will be followed for 2 weeks after the up adjustment procedure, after which the study ends. Subjects will be given the option to continue the implantation period until 52 weeks.
- Conditions
- Overweight and Obesity
- Being tested
- Spatz4 Adjustable Balloon System
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatz4 Adjustable Balloon SystemDevice
The Spatz4 Adjustable Balloon System is designed to assist weight loss by partially filling the stomach and inducing satiety. The intragastrical balloon is implanted endoscopically for up to 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Spatz4 subjects | Experimental | Subjects will be studied in an open label multi-center center study which will examine the usability of the adjustment process and success of the process. . Receives: Device: Spatz4 Adjustable Balloon System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful adjustment procedure at 16 ±2 weeks in > 90% of attempts
Proportion of subjects with successful adjustment procedure is greater than 90%
Measured: 16±2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start14 Jun 2022
- Primary completion29 Aug 2023
- Study completion29 Aug 2023
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spatz FGIA, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MANOEL GALVAO NETO, MD, Principal investigator, Fundação do ABC - FMABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007964
- Sponsor's protocol ID
- Spatz4-001
- Status last verified
- Apr 2024
- First submitted
- 9 Aug 2021
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4).
- ClinicalTrials.gov ID
- NCT05007964
- Acronym / sponsor ID
- Spatz4-001
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Spatz FGIA, IncUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 17 Aug 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 evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27.
Up to 66 eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz4 balloon. All subjects will follow a calorie restricted diet designed by the dietician. An up adjustment will be performed at 16 weeks (±2 weeks). The subjects will be followed for 2 weeks after the up adjustment procedure, after which the study ends. Subjects will be given the option to continue the implantation period until 52 weeks.
Detailed description
The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27.
Subjects will be studied in an open label multi-center center study that will have one endpoint at 20 weeks. Up to 66 eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz4 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 450 to 550 ml of 0.9% normal saline with 2 ml of a 1% solution of methylene blue. It is estimated, based on clinical studies, that approximately 10% of subjects will be intolerant in the first month and will require a down adjustment, wherein 150 ml of fluid will be removed from the balloon. An up adjustment will be performed at 16 weeks (±2 weeks) with the addition of 200-300 ml of 0.9% normal saline. The balloon adjustment procedure is done with an endoscopy procedure under the same sedation as the implantation procedure.
The subjects will be followed for 2 weeks after the up adjustment procedure, after which the study ends. Subjects will be given the option to continue the implantation period until 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spatz4 subjects | Experimental | Device: Spatz4 Adjustable Balloon SystemSubjects will be studied in an open label multi-center center study which will examine the usability of the adjustment process and success of the process. . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| Spatz4 Adjustable Balloon SystemThe Spatz4 Adjustable Balloon System is designed to assist weight loss by partially filling the stomach and inducing satiety. The intragastrical balloon is implanted endoscopically for up to 12 months. | Device | Spatz4 subjects |
Primary outcome
Successful adjustment procedure at 16 ±2 weeks in > 90% of attempts
Time frame: 16±2 weeks
Proportion of subjects with successful adjustment procedure is greater than 90%
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 4 Dec 2024.
- Individual participant dataSharing planned: No
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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.
MANOEL GALVAO NETO, MD principal investigator
Fundação do ABC - FMABC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spatz4 Adjustable Balloon System in people with Overweight and Obesity, run by Spatz FGIA, Inc at 1 site in Brazil.
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 4 Dec 2024. 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 Brazil. 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?
Successful adjustment procedure at 16 ±2 weeks in > 90% of attempts (time frame: 16±2 weeks). 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 4 Dec 2024.