ObesitySABONCT02812160
Spatz Adjustable Balloon for Obesity (SABO)
A study testing Spatz3 Adjustable Balloon in people with Obesity, run by Spatz FGIA, Inc at 7 sites in United States.
Trial summary
The purpose of this study is to determine whether the Spatz3 Adjustable balloon, a non-surgical device, is effective in the treatment of obesity. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Spatz3 Adjustable Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 7 sitesUnited States
- Study dates
- 12 Sep 2016to Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 22 - 65
- BMI ≥ 30 and <40
- Willingness to comply with the substantial lifelong dietary restrictions required by the procedure
- History of obesity (BMI ≥ 30) for at least 2 years
- History of failure with non-surgical weight loss methods
- Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, completing diet counseling
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- Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits
- Ability to give informed consent
- Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods. Acceptable birth control methods are limited to hormonal contraceptives (oral, flexible vaginal ring, skin patch, injection), diaphragms, IUDs, condoms with or without spermicide, and voluntary abstinence. The method of birth control must be documented and verified at follow-up. Should a treatment arm subject become pregnant during the implantation period, the balloon will be extracted during the second trimester - the timing of which will be determined via consultation with the subject's obstetrician.
Who cannot join
- Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
- Prior open or laparoscopic bariatric surgery.
- Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.
- Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
- Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
- A gastric mass.
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- A hiatal hernia > 2cm or severe or intractable gastro-esophageal reflux symptoms.
- Acid reflux symptoms to any degree that require more than one medication for symptom control.
- A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope.
- Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device
- Severe coagulopathy.
- Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months.
- Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy
- Chronic abdominal pain
- Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation
- Hepatic insufficiency or cirrhosis
- Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 8 months.
- Alcoholism or drug addiction.
- Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
- Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.
- Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
- Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.
- Patients who have ever developed a serotonin syndrome and are currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)] should not undergo placement of the device.
- Patients who are pregnant or breast-feeding.
- Subjects with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 months, poorly-controlled hypertension, required use of NSAIDs
- Subjects who have tested positive for H. Pylori.
- Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
- Subjects who are taking corticosteroids, immunosuppressants, and narcotics
- Subjects who are taking diet pills
- Use of an intragastric device prior to this study due to the potential increase in risk associated with implantation of a balloon in a previously instrumented and possibly scarred stomach.
- Participation in any clinical study which could affect weight loss within the past 6 months due to the potential to confound findings.
- Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
- Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
- Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.
- Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator because of an increased risk profile.
- Specific diagnosed genetic or hormonal cause for obesity such as hypothyroidism or Prader Willi syndrome
- Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
- Known history of endocrine disorders affecting weight
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Brigham and Womans Hospital
Boston, Massachusetts, 02115
University of Chicago
Chicago, Illinois, 60637
Ohio State University
Columbus, Ohio, 43210
Surgical Specialists of Louisiana
Metairie, Louisiana, 70001
NY Manhattan VA Hospital
New York, New York, 10010
Mayo Clinic
Rochester, Minnesota, 55905
Endoscopic MicroSurgery Associates
Towson, Maryland, 21204
About this study
Official title: A Randomized, Controlled, Multicenter Study Comparing the Spatz3 Adjustable Balloon System Plus Diet and Exercise to Diet and Exercise Alone
The purpose of this study is to determine whether the Spatz3 Adjustable balloon, a non-surgical device, is effective in the treatment of obesity.
Read the detailed description
Device Name: Spatz3 Adjustable Balloon System® (Spatz3) Clinical Phase: Pivotal Trial Design: Multicenter open-label randomized controlled trial Trial Participants: Adults, ages 22-65, with a BMI ≥ 30 and < 40 who have failed to achieve and maintain weight-loss with a weight control program Control group: Supervised diet and exercise Planned sample size: 282 subjects randomized 2:1 to device/control study treatment duration: 32 weeks Primary endpoint: Percent change in total body weight (%TBL) at 32 weeks
- Conditions
- Obesity
- Being tested
- Spatz3 Adjustable Balloon
- Keywords
- weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatz3 Adjustable BalloonDevice
An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed
| Study group | Role | What they receive |
|---|---|---|
| Spatz3 Adjustable Balloon | Active comparator | Spatz3 Adjustable Balloon with Dietary and exercise counselling Receives: Device: Spatz3 Adjustable Balloon |
| Control | No intervention | Dietary and Exercise counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Total Body Weight (%TBL) .
The mean %TBL in the Spatz3 group should exceed the %TBL control group by 4.5%.
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study start12 Sep 2016
- Primary completionOct 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spatz FGIA, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barham AbuDayyeh, MD, Principal investigator, Mayo ClinicChristopher C Thompson, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812160
- Sponsor's protocol ID
- Spatz-160061
- Acronym
- SABO
- Status last verified
- May 2021
- First submitted
- 25 May 2016
- Last updated
- 28 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Abu Dayyeh BK, Maselli DB, Rapaka B, Lavin T, Noar M, Hussan H, Chapman CG, Popov V, Jirapinyo P, Acosta A, Vargas EJ, Storm AC, Bazerbachi F, Ryou M, French M, Noria S, Molina D, Thompson CC. Adjustable intragastric balloon for treatment of obesity: a multicentre, open-label, randomised clinical trial. Lancet. 2021 Nov 27;398(10315):1965-1973. doi: 10.1016/S0140-6736(21)02394-1. Epub 2021 Nov 15.
PubMed 34793746
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter Study Comparing the Spatz3 Adjustable Balloon System Plus Diet and Exercise to Diet and Exercise Alone
- ClinicalTrials.gov ID
- NCT02812160
- Acronym / sponsor ID
- SABO / Spatz-160061
- Conditions
- Obesity
- Keywords
- weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Spatz FGIA, IncUniversity, hospital or other
- Study start
- 12 Sep 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Posted 28 May 2021
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 determine whether the Spatz3 Adjustable balloon, a non-surgical device, is effective in the treatment of obesity.
Detailed description
Device Name: Spatz3 Adjustable Balloon System® (Spatz3) Clinical Phase: Pivotal Trial Design: Multicenter open-label randomized controlled trial Trial Participants: Adults, ages 22-65, with a BMI ≥ 30 and < 40 who have failed to achieve and maintain weight-loss with a weight control program Control group: Supervised diet and exercise Planned sample size: 282 subjects randomized 2:1 to device/control study treatment duration: 32 weeks Primary endpoint: Percent change in total body weight (%TBL) at 32 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spatz3 Adjustable Balloon | Active comparator | Device: Spatz3 Adjustable BalloonSpatz3 Adjustable Balloon with Dietary and exercise counselling |
| Control | No intervention | –Dietary and Exercise counselling |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 22 - 65
- BMI ≥ 30 and <40
- Willingness to comply with the substantial lifelong dietary restrictions required by the procedure
- History of obesity (BMI ≥ 30) for at least 2 years
- History of failure with non-surgical weight loss methods
Key exclusion criteria (38 listed)
- Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
- Prior open or laparoscopic bariatric surgery.
- Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.
- Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
- Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
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 |
|---|---|---|
| Spatz3 Adjustable BalloonAn adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed | Device | Spatz3 Adjustable Balloon |
Primary outcome
Percent Change in Total Body Weight (%TBL) .
Time frame: 32 weeks
The mean %TBL in the Spatz3 group should exceed the %TBL control group by 4.5%.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34793746Abu Dayyeh BK, Maselli DB, Rapaka B, Lavin T, Noar M, Hussan H, Chapman CG, Popov V, Jirapinyo P, Acosta A, Vargas EJ, Storm AC, Bazerbachi F, Ryou M, French M, Noria S, Molina D, Thompson CC. Adjustable intragastric balloon for treatment of obesity: a multicentre, open-label, randomised clinical trial. Lancet. 2021 Nov 27;398(10315):1965-1973. doi: 10.1016/S0140-6736(21)02394-1. Epub 2021 Nov 15.
- Individual participant dataSharing planned: Undecided
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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.
Barham AbuDayyeh, MD principal investigator
Mayo Clinic
Christopher C Thompson, MD principal investigator
Brigham and Women's Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spatz3 Adjustable Balloon in people with Obesity, run by Spatz FGIA, Inc at 7 sites in United States.
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 38 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 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Yes. Results are posted in the registry (first posted 28 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02812160, which also lists 1 linked publication.
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 May 2021.