Trial Outcomes & Findings for Obalon Balloon System Pivotal IDE (SMART) Trial (NCT NCT02235870)
NCT ID: NCT02235870
Last Updated: 2018-03-08
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
711 participants
Primary outcome timeframe
24 Weeks
Results posted on
2018-03-08
Participant Flow
711 subjects signed an informed consent form to participate in the study and proceeded to the screening eligibility process
430 subjects randomized in a Treatment or Control group, 387 subjects received an Obalon Balloon or Sham Device.
Participant milestones
| Measure |
Obalon Treatment Group
Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
|
Sham Control Group
Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
198
|
189
|
|
Overall Study
Completed Phase I (Week 24)
|
182
|
179
|
|
Overall Study
Crossover (Week 24)
|
170
|
138
|
|
Overall Study
COMPLETED
|
160
|
128
|
|
Overall Study
NOT COMPLETED
|
38
|
61
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Obalon Balloon System Pivotal IDE (SMART) Trial
Baseline characteristics by cohort
| Measure |
Obalon Treatment Group
n=198 Participants
Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
|
Sham Control Group
n=189 Participants
Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
|
Total
n=387 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
42.5 years
STANDARD_DEVIATION 9.3 • n=107 Participants
|
42.6 years
STANDARD_DEVIATION 9.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=99 Participants
|
170 Participants
n=107 Participants
|
341 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
183 Participants
n=99 Participants
|
165 Participants
n=107 Participants
|
348 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
165 Participants
n=99 Participants
|
155 Participants
n=107 Participants
|
320 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
35.2 kg/m^2
STANDARD_DEVIATION 2.7 • n=99 Participants
|
35.5 kg/m^2
STANDARD_DEVIATION 2.7 • n=107 Participants
|
35.4 kg/m^2
STANDARD_DEVIATION 2.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: Per Protocol cohort which includes subjects with at least 2 devices for at least 18 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
Outcome measures
| Measure |
Obalon Treatment Group
n=185 Participants
Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
|
Sham Control Group
n=181 Participants
Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
|
|---|---|---|
|
Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups
|
6.86 %TBL
Standard Error 0.37
|
3.59 %TBL
Standard Error 0.37
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Per Protocol cohort which includes subjects in the Obalon Treatment group with at least 2 balloons for at least 18 weeks
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%
Outcome measures
| Measure |
Obalon Treatment Group
n=185 Participants
Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
|
Sham Control Group
Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
|
|---|---|---|
|
Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL)
|
120 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 MonthsPopulation: Per Protocol cohort which includes subjects with at least 2 devices for at least 18 weeks
Difference in percentage of subjects between the Obalon Treatment and Sham Control groups with at least 5% Total Body Loss (TBL)
Outcome measures
| Measure |
Obalon Treatment Group
n=185 Participants
Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
|
Sham Control Group
n=181 Participants
Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks
|
|---|---|---|
|
Percentage of Subjects With at Least 5% Total Body Loss: Obalon - Sham Group
|
120 Participants
|
58 Participants
|
Adverse Events
Treated Subjects
Serious events: 7 serious events
Other events: 321 other events
Deaths: 0 deaths
Control Subjects
Serious events: 5 serious events
Other events: 221 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treated Subjects
n=336 participants at risk
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
n=359 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Peptic ulcer disease
|
0.30%
1/336 • Number of events 1 • Six months
|
0.00%
0/359 • Six months
|
|
Reproductive system and breast disorders
Abnormal Pap Smear
|
0.30%
1/336 • Number of events 1 • Six months
|
0.00%
0/359 • Six months
|
|
Surgical and medical procedures
Synovectomy
|
0.00%
0/336 • Six months
|
0.28%
1/359 • Number of events 1 • Six months
|
|
Reproductive system and breast disorders
Breast Cancer
|
0.30%
1/336 • Number of events 1 • Six months
|
0.00%
0/359 • Six months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/336 • Six months
|
0.28%
1/359 • Number of events 1 • Six months
|
|
Infections and infestations
Bacterial Meningitis
|
0.30%
1/336 • Number of events 1 • Six months
|
0.00%
0/359 • Six months
|
|
Infections and infestations
Wound Infection
|
0.00%
0/336 • Six months
|
0.28%
1/359 • Number of events 1 • Six months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.60%
2/336 • Number of events 2 • Six months
|
0.00%
0/359 • Six months
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.30%
1/336 • Number of events 1 • Six months
|
0.00%
0/359 • Six months
|
|
Congenital, familial and genetic disorders
Chiari Malformation
|
0.00%
0/336 • Six months
|
0.28%
1/359 • Number of events 1 • Six months
|
|
General disorders
Heel Exostosis
|
0.00%
0/336 • Six months
|
0.28%
1/359 • Number of events 1 • Six months
|
|
Infections and infestations
Sepsis
|
0.00%
0/336 • Six months
|
0.28%
1/359 • Number of events 1 • Six months
|
Other adverse events
| Measure |
Treated Subjects
n=336 participants at risk
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
n=359 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
73.2%
246/336 • Number of events 501 • Six months
|
14.2%
51/359 • Number of events 65 • Six months
|
|
Gastrointestinal disorders
Nausea
|
56.8%
191/336 • Number of events 315 • Six months
|
10.3%
37/359 • Number of events 43 • Six months
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
61/336 • Number of events 75 • Six months
|
4.5%
16/359 • Number of events 16 • Six months
|
|
Gastrointestinal disorders
Dyspepsia
|
17.9%
60/336 • Number of events 73 • Six months
|
2.8%
10/359 • Number of events 11 • Six months
|
|
Gastrointestinal disorders
Abdominal Distension
|
14.6%
49/336 • Number of events 54 • Six months
|
2.8%
10/359 • Number of events 12 • Six months
|
|
Gastrointestinal disorders
Eructation
|
9.2%
31/336 • Number of events 37 • Six months
|
0.00%
0/359 • Six months
|
|
Gastrointestinal disorders
Diarrhea
|
12.2%
41/336 • Number of events 47 • Six months
|
4.2%
15/359 • Number of events 16 • Six months
|
|
Gastrointestinal disorders
Gastric Irritation
|
7.1%
24/336 • Number of events 25 • Six months
|
0.00%
0/359 • Six months
|
|
Gastrointestinal disorders
Gastric Bleeding/Abrasion
|
5.1%
17/336 • Number of events 17 • Six months
|
0.00%
0/359 • Six months
|
|
Gastrointestinal disorders
Constipation
|
15.2%
51/336 • Number of events 57 • Six months
|
10.3%
37/359 • Number of events 47 • Six months
|
|
Infections and infestations
Common Cold/Upper Respiratory Infection
|
13.7%
46/336 • Number of events 56 • Six months
|
12.3%
44/359 • Number of events 50 • Six months
|
|
Infections and infestations
Stomach/Seasonal Flu
|
8.6%
29/336 • Number of events 32 • Six months
|
7.0%
25/359 • Number of events 28 • Six months
|
|
Metabolism and nutrition disorders
Headache/Migraine
|
6.5%
22/336 • Number of events 25 • Six months
|
7.2%
26/359 • Number of events 30 • Six months
|
Additional Information
Amy VandenBerg, Vice-President, Clinical Affairs and Regulatory Affairs
Obalon Therapeutics, Inc.
Phone: 760.795.6551
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place