Obalon Balloon System Pivotal IDE (SMART) Trial

• Sponsor: Obalon Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02235870
• Collaborator: (none)
• Enrollment: 711
• Locations: 15
• Arms: 2
• Duration (Months): 14.9
• Patients Per Site: 47.4
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

This pivotal trial of the Obalon Balloon System is intended to generate safety and effectiveness data required to support a future marketing application. The trial has been designed to evaluate a 6-month use of the Obalon Balloon System as an adjunct to a nutrition and lifestyle behavior modification program.

Weight loss will be evaluated after the 6-month course to determine if a specific predefined superiority margin can be achieved in the device group compared to a sham-control group.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Device: Obalon Intragastric Balloons; Device: Sham Device; Behavioral: Nutrition and Lifestyle Program	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 711 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Six-Month Adjunctive Weight Reduction Therapy (SMART) Trial
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment Group In accordance with the randomization assignment, treatment arm subjects will receive a 6-month course of Balloon therapy with a nutrition and lifestyle program. Balloon treatment consists of placement of 3 balloons Obalon Intragastric Balloons in the first 3 months of therapy.	Device: Obalon Intragastric Balloons; Intragastric Balloon System to aid in portion control.; Behavioral: Nutrition and Lifestyle Program; Nutrition and lifestyle program reviewed with subjects every 3 weeks for 6 months.
Sham Comparator: Control Group Control arm subjects will receive a single 6-month course of sham device therapy with a nutrition and lifestyle program. Sham treatment consists of placement of 3 shams in the first 3 months of therapy.	Device: Sham Device; Sham Intragastric Balloon; Behavioral: Nutrition and Lifestyle Program; Nutrition and lifestyle program reviewed with subjects every 3 weeks for 6 months.

Outcome Measures

Primary Outcome Measures

1. Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups [24 Weeks]

   Statistical test to determine if the least-square mean difference between the Obalon Treatment and Sham Control groups is greater than the 2.1% TBL superiority margin

2. Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL) [6 months]

   Statistical test to determine if the percentage of subjects in the Obalon Treatment and Sham Control with at least 5% Total Body Loss (TBL) is greater than 35%

Other Outcome Measures

1. Percentage of Subjects With at Least 5% Total Body Loss: Obalon - Sham Group [6 Months]

   Difference in percentage of subjects between the Obalon Treatment and Sham Control groups with at least 5% Total Body Loss (TBL)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female between the ages of 22-64 years

2. Current BMI of 30.0 - 40 kg/m2

3. Previously attempted to lose weight unsuccessfully using a medically supervised or non-medically supervised diet

4. Willing to attend all protocol-specified follow-up visits plus any additional follow-up visits as required throughout the entire study period

5. Willing to avoid non-commercial air travel and scuba diving during the entire study period

6. Willing to avoid medications or other substances known to effect weight changes during the study

7. Willing to avoid Non-Steroidal Anti-inflammatory Drugs (NSAIDs) or other medications known to be gastric irritants during the study

8. Willing to use contraception and avoid pregnancy during the study if the subject is female with child bearing potential

9. Willing to provide written informed consent

Exclusion Criteria:

1. Significant weight loss in the past 12 months

2. Use of medications or other substances known to induce weight gain or weight loss

3. Participation in any clinical study at the start of this trial or in the last year

4. Known history of endocrine disorders affecting weight

5. Currently receiving chronic steroid or immunosuppressive therapy or has previously been diagnosed with HIV

6. Subjects diagnosed with bulimia, binge eating, compulsive overeating, high liquid calorie intake habits or similar eating related psychological disorders

7. Intent to undergo gastric surgery or gastric banding during the study period or within the 6 month period after completion of this study

8. Prior use of any weight loss medical device

9. Known history of structural or functional disorders of the esophagus

10. Known history of structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms

11. Known history of structural or functional disorders of the stomach

12. Known history of a structural or functional disorder of the stomach, including any symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic dyspepsia or symptoms suggestive of gastroparesis, including post-prandial fullness or pain, post-prandial nausea or vomiting or early satiety

13. Known history of duodenal ulcer, intestinal diverticula (diverticulitis), intestinal varices, intestinal stricture/stenosis, small bowel obstruction, or any other obstructive disorder of the gastrointestinal (GI) tract

14. Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting

15. Known history irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease

16. Known history of GI surgeries that may have resulted in anatomical GI tract abnormalities

17. Type 1 diabetes

18. Type 2 diabetes requiring insulin or other hypoglycemic oral agents.

19. Experienced a myocardial infarction, has a known history of angina, a known history of congestive heart failure, or is currently being medically treated for any other cardiac condition

20. Poorly controlled hypertension, (≥ 160 mmHg Systolic and ≥ 100mmHg Diastolic).

21. End stage renal disease or requiring hemodialysis within the past 6 months

22. Unwilling or unable to avoid Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Aspirin, Diclofenac, Ibuprofen, Naproxen, or other medications known to be gastric irritants beginning two weeks prior to enrollment and throughout the entire study period

23. Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying

24. Subjects requiring the use of anti-platelet drugs or other agents affecting the normal clotting of blood

25. Untreated or unstable alcohol or illicit drug addiction

26. Known history of allergies to any component of the device materials

27. Currently pregnant or breastfeeding or intention of becoming pregnant during the study

28. Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator

29. Subject is employed by the investigator, or is a close relative of the investigator, or the investigator's staff

30. Subject is a close relative of another subject already enrolled in the study.

31. Any other condition that, in the opinion of the investigator, would interfere with subject participation, may confound the study results, or interfere with compliance with the study (e.g., psychosocial issues).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HonorHealth Research Institute	Scottsdale	Arizona	United States
2	Anaheim Clinical Trials	Anaheim	California	United States
3	Southern California Research Center	Coronado	California	United States
4	Bariatric Institute of Greater Chicago	Hinsdale	Illinois	United States
5	Endoscopic Microsurgery Associates	Towson	Maryland	United States
6	Saint Luke's Hospital of Kansas City	Kansas City	Missouri	United States
7	Washington University Hospital in St. Louis	Saint Louis	Missouri	United States
8	Stony Brook Medicine	Stony Brook	New York	United States
9	West Penn Hospital	Pittsburgh	Pennsylvania	United States
10	Chattanooga Bariatrics	Chattanooga	Tennessee	United States
11	Midsouth Bariatrics	Memphis	Tennessee	United States
12	Vanderbilt University Medical Center	Nashville	Tennessee	United States
13	Houston Methodist Research Institute	Houston	Texas	United States
14	University of Utah Hospital	Salt Lake City	Utah	United States
15	Virginia Mason Medical Center	Seattle	Washington	United States

Sponsors and Collaborators

• Obalon Therapeutics, Inc.

Investigators

• Study Chair: Amy VandenBerg, Obalon Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Obalon Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT02235870
• Other Study ID Numbers: PTL-1100-0013
• First Posted: Sep 10, 2014
• Last Update Posted: Mar 8, 2018
• Last Verified: Feb 1, 2018

• Keywords provided by Obalon Therapeutics, Inc.: Weight Loss; Obesity; BMI
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Recruitment Details	711 subjects signed an informed consent form to participate in the study and proceeded to the screening eligibility process
Pre-assignment Detail	430 subjects randomized in a Treatment or Control group, 387 subjects received an Obalon Balloon or Sham Device.

Arm/Group Title	Obalon Treatment Group	Sham Control Group
Arm/Group Description	Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks	Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
Period Title: Overall Study
STARTED	198	189
Completed Phase I (Week 24)	182	179
Crossover (Week 24)	170	138
COMPLETED	160	128
NOT COMPLETED	38	61

Baseline Characteristics

Arm/Group Title	Obalon Treatment Group	Sham Control Group	Total
Arm/Group Description	Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks	Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks	Total of all reporting groups
Overall Participants	198	189	387
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.6 (9.6)	42.5 (9.3)	42.6 (9.4)
Sex: Female, Male (Count of Participants)
Female	171 86.4%	170 89.9%	341 88.1%
Male	27 13.6%	19 10.1%	46 11.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	15 7.6%	24 12.7%	39 10.1%
Not Hispanic or Latino	183 92.4%	165 87.3%	348 89.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.5%	1 0.3%
Asian	1 0.5%	1 0.5%	2 0.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	21 10.6%	29 15.3%	50 12.9%
White	165 83.3%	155 82%	320 82.7%
More than one race	11 5.6%	3 1.6%	14 3.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	35.2 (2.7)	35.5 (2.7)	35.4 (2.7)

Outcome Measures

1. Primary Outcome

Title	Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups
Description	Statistical test to determine if the least-square mean difference between the Obalon Treatment and Sham Control groups is greater than the 2.1% TBL superiority margin
Time Frame	24 Weeks

Outcome Measure Data

Analysis Population Description

Per Protocol cohort which includes subjects with at least 2 devices for at least 18 weeks

Arm/Group Title	Obalon Treatment Group	Sham Control Group
Arm/Group Description	Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks	Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
Measure Participants	185	181
Least Squares Mean (Standard Error) [%TBL]	6.86 (0.37)	3.59 (0.37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Obalon Treatment Group, Sham Control Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0261
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least-Square Mean Difference
	Estimated Value	3.28
	Confidence Interval	(2-Sided) 95%; 2.24 to 4.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL)
Description	Statistical test to determine if the percentage of subjects in the Obalon Treatment and Sham Control with at least 5% Total Body Loss (TBL) is greater than 35%
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Per Protocol cohort which includes subjects in the Obalon Treatment group with at least 2 balloons for at least 18 weeks

Arm/Group Title	Obalon Treatment Group
Arm/Group Description	Subjects who received the Obalon Balloons.
Measure Participants	185
Count of Participants [Participants]	120 60.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Obalon Treatment Group
	Comments	Subjects in the Obalon Treatment group with at least 2 Balloons and balloon therapy for at least 18 weeks.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Exact Test
	Comments
Method of Estimation	Estimation Parameter	Exact Confidence Interval
	Estimated Value	64.9
	Confidence Interval	(2-Sided) 95%; 57.5 to 71.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Other Pre-specified Outcome

Title	Percentage of Subjects With at Least 5% Total Body Loss: Obalon - Sham Group
Description	Difference in percentage of subjects between the Obalon Treatment and Sham Control groups with at least 5% Total Body Loss (TBL)
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Per Protocol cohort which includes subjects with at least 2 devices for at least 18 weeks

Arm/Group Title	Obalon Treatment Group	Sham Control Group
Arm/Group Description	Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks	Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
Measure Participants	185	181
Count of Participants [Participants]	120 60.6%	58 30.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Obalon Treatment Group, Sham Control Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	32.8
	Confidence Interval	(2-Sided) 95%; 23.1 to 42.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Six months
Arm/Group Title	Treated Subjects		Control Subjects
Arm/Group Description	Treated subjects include the 198 subjects in Phase I of the study who received at least 1 Obalon Balloon and the 138 subjects in Phase II who crossover and received at least 1 Obalon Balloon		Control subjects include the 189 subjects in Phase I of the study who received at least 1 Sham Device and the 170 subjects in Phase II who were followed after balloon removal
All Cause Mortality
	Treated Subjects		Control Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/336 (0%)		0/359 (0%)
Serious Adverse Events
	Treated Subjects		Control Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/336 (2.1%)		5/359 (1.4%)
Congenital, familial and genetic disorders
Chiari Malformation	0/336 (0%)	0	1/359 (0.3%)	1
Gastrointestinal disorders
Peptic ulcer disease	1/336 (0.3%)	1	0/359 (0%)	0
General disorders
Heel Exostosis	0/336 (0%)	0	1/359 (0.3%)	1
Hepatobiliary disorders
Cholelithiasis	2/336 (0.6%)	2	0/359 (0%)	0
Infections and infestations
Pyelonephritis	0/336 (0%)	0	1/359 (0.3%)	1
Bacterial Meningitis	1/336 (0.3%)	1	0/359 (0%)	0
Wound Infection	0/336 (0%)	0	1/359 (0.3%)	1
Sepsis	0/336 (0%)	0	1/359 (0.3%)	1
Reproductive system and breast disorders
Abnormal Pap Smear	1/336 (0.3%)	1	0/359 (0%)	0
Breast Cancer	1/336 (0.3%)	1	0/359 (0%)	0
Surgical and medical procedures
Synovectomy	0/336 (0%)	0	1/359 (0.3%)	1
Knee Arthroplasty	1/336 (0.3%)	1	0/359 (0%)	0
Other (Not Including Serious) Adverse Events
	Treated Subjects		Control Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	321/336 (95.5%)		221/359 (61.6%)
Gastrointestinal disorders
Abdominal Pain	246/336 (73.2%)	501	51/359 (14.2%)	65
Nausea	191/336 (56.8%)	315	37/359 (10.3%)	43
Vomiting	61/336 (18.2%)	75	16/359 (4.5%)	16
Dyspepsia	60/336 (17.9%)	73	10/359 (2.8%)	11
Abdominal Distension	49/336 (14.6%)	54	10/359 (2.8%)	12
Eructation	31/336 (9.2%)	37	0/359 (0%)	0
Diarrhea	41/336 (12.2%)	47	15/359 (4.2%)	16
Gastric Irritation	24/336 (7.1%)	25	0/359 (0%)	0
Gastric Bleeding/Abrasion	17/336 (5.1%)	17	0/359 (0%)	0
Constipation	51/336 (15.2%)	57	37/359 (10.3%)	47
Infections and infestations
Common Cold/Upper Respiratory Infection	46/336 (13.7%)	56	44/359 (12.3%)	50
Stomach/Seasonal Flu	29/336 (8.6%)	32	25/359 (7%)	28
Metabolism and nutrition disorders
Headache/Migraine	22/336 (6.5%)	25	26/359 (7.2%)	30

Limitations/Caveats

[Not Specified]

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.