Spatz Adjustable Balloon for Obesity (SABO)

• Sponsor: Spatz FGIA, Inc (Other)
• Overall Status: Completed
• CT.gov ID: NCT02812160
• Collaborator: (none)
• Enrollment: 288
• Locations: 7
• Arms: 2
• Actual Duration (Months): 27.6
• Patients Per Site: 41.1
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Device: Spatz3 Adjustable Balloon	N/A

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

• Study Type: Interventional
• Actual Enrollment: 288 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Controlled, Multicenter Study Comparing the Spatz3 Adjustable Balloon System Plus Diet and Exercise to Diet and Exercise Alone
• Actual Study Start Date: Sep 12, 2016
• Actual Primary Completion Date: Oct 1, 2018
• Actual Study Completion Date: Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Spatz3 Adjustable Balloon Spatz3 Adjustable Balloon with Dietary and exercise counselling	Device: Spatz3 Adjustable Balloon; An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed
No Intervention: Control Dietary and Exercise counselling

Outcome Measures

Primary Outcome Measures

1. Percent Change in Total Body Weight (%TBL) . [32 weeks]

   The mean %TBL in the Spatz3 group should exceed the %TBL control group by 4.5%.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age 22 - 65

2. BMI ≥ 30 and <40

3. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure

4. History of obesity (BMI ≥ 30) for at least 2 years

5. History of failure with non-surgical weight loss methods

6. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, completing diet counseling

7. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits

8. Ability to give informed consent

9. 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.

Exclusion Criteria:

1. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.

2. Prior open or laparoscopic bariatric surgery.

3. Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.

4. 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.

5. 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.

6. A gastric mass.

7. A hiatal hernia > 2cm or severe or intractable gastro-esophageal reflux symptoms.

8. Acid reflux symptoms to any degree that require more than one medication for symptom control.

9. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope.

10. Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device

11. Severe coagulopathy.

12. Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months.

13. Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy

14. Chronic abdominal pain

15. Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation

16. Hepatic insufficiency or cirrhosis

17. 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.

18. Alcoholism or drug addiction.

19. Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.

20. Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.

21. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.

22. Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.

23. 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.

24. Patients who are pregnant or breast-feeding.

25. 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

26. Subjects who have tested positive for H. Pylori.

27. Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications

28. Subjects who are taking corticosteroids, immunosuppressants, and narcotics

29. Subjects who are taking diet pills

30. 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.

31. Participation in any clinical study which could affect weight loss within the past 6 months due to the potential to confound findings.

32. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.

33. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.

34. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.

35. 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.

36. Specific diagnosed genetic or hormonal cause for obesity such as hypothyroidism or Prader Willi syndrome

37. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating

38. Known history of endocrine disorders affecting weight

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637
2	Surgical Specialists of Louisiana	Metairie	Louisiana	United States	70001
3	Endoscopic MicroSurgery Associates	Towson	Maryland	United States	21204
4	Brigham and Womans Hospital	Boston	Massachusetts	United States	02115
5	Mayo Clinic	Rochester	Minnesota	United States	55905
6	NY Manhattan VA Hospital	New York	New York	United States	10010
7	Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Spatz FGIA, Inc

Investigators

• Principal Investigator: Barham AbuDayyeh, MD, Mayo Clinic
• Principal Investigator: Christopher C Thompson, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 11, 2017

More Information

Publications

None provided.

• Responsible Party: Spatz FGIA, Inc
• ClinicalTrials.gov Identifier: NCT02812160
• Other Study ID Numbers: Spatz-160061
• First Posted: Jun 24, 2016
• Last Update Posted: May 28, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Spatz FGIA, Inc: weight loss
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Arm/Group Title	Spatz3 Adjustable Balloon	Control
Arm/Group Description	Spatz3 Adjustable Balloon with Dietary and exercise counselling Spatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed	Dietary and Exercise counselling
Period Title: Overall Study
STARTED	187	101
COMPLETED	187	101
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Spatz3 Adjustable Balloon	Control	Total
Arm/Group Description	Spatz3 Adjustable Balloon with Dietary and exercise counselling Spatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed	Dietary and Exercise counselling	Total of all reporting groups
Overall Participants	187	101	288
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	187 100%	101 100%	288 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.4 (8.9)	44.0 (8.9)	44.3 (8.9)
Sex: Female, Male (Count of Participants)
Female	162 86.6%	90 89.1%	252 87.5%
Male	25 13.4%	11 10.9%	36 12.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 0.5%	1 1%	2 0.7%
Native Hawaiian or Other Pacific Islander	1 0.5%	0 0%	1 0.3%
Black or African American	49 26.2%	26 25.7%	75 26%
White	132 70.6%	72 71.3%	204 70.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	4 2.1%	2 2%	6 2.1%
Region of Enrollment (Count of Participants)
United States	187 100%	101 100%	288 100%
BMI (Kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg/m^2]	35.8 (2.6)	35.8 (2.7)	35.8 (2.6)

Outcome Measures

1. Primary Outcome

Title	Percent Change in Total Body Weight (%TBL) .
Description	The mean %TBL in the Spatz3 group should exceed the %TBL control group by 4.5%.
Time Frame	32 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spatz3 Adjustable Balloon	Control
Arm/Group Description	Spatz3 Adjustable Balloon with Dietary and exercise counselling Spatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed	Dietary and Exercise counselling
Measure Participants	187	101
Mean (Standard Deviation) [TBL%]	15.0 (7.2)	3.3 (5.6)

Adverse Events

Time Frame	32 weeks
Arm/Group Title	Spatz3 Adjustable Balloon		Control
Arm/Group Description	Spatz3 Adjustable Balloon with Dietary and exercise counselling Spatz3 Adjustable Balloon: An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed		Dietary and Exercise counselling
All Cause Mortality
	Spatz3 Adjustable Balloon		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/187 (0%)		0/101 (0%)
Serious Adverse Events
	Spatz3 Adjustable Balloon		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/187 (5.3%)		1/101 (1%)
Gastrointestinal disorders
Gastrointestinal disorders	7/187 (3.7%)	24	1/101 (1%)	1
Metabolism and nutrition disorders
Metabolism and nutrition disorders	4/187 (2.1%)	5	0/101 (0%)	0
Other (Not Including Serious) Adverse Events
	Spatz3 Adjustable Balloon		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	184/187 (98.4%)		32/101 (31.7%)
Gastrointestinal disorders
Gastrointestinal disorders	184/187 (98.4%)	2522	32/101 (31.7%)	84

Limitations/Caveats

There are no overall Limitations and Caveats

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.