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Obalon Balloon System Pivotal IDE (SMART) Trial (SMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02235870
Recruitment Status : Completed
First Posted : September 10, 2014
Results First Posted : March 8, 2018
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Obalon Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Obesity
Interventions Device: Obalon Intragastric Balloons
Device: Sham Device
Behavioral: Nutrition and Lifestyle Program
Enrollment 711
Recruitment Details 711 subjects signed an informed consent form to participate in the study and proceeded to the screening eligibility process
Pre-assignment Details 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
Hide 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 [1] 198 189
Completed Phase I (Week 24) [2] 182 179
Crossover (Week 24) [3] 170 138
Completed [4] 160 128
Not Completed 38 61
[1]
Subjects, Registered Dietitians and Adverse Event Assessors were blinded of device assignment
[2]
Device assignment unblinding and Obalon Balloon removal for Treatment Group
[3]
Sham Group received Obalon Balloon & Treatment Group followed after balloon removal (WLBM for both)
[4]
Completed Phase II (Week 48), Obalon Balloon removal for Sham Group
Arm/Group Title Obalon Treatment Group Sham Control Group Total
Hide 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 Number of Baseline Participants 198 189 387
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 198 participants 189 participants 387 participants
42.6  (9.6) 42.5  (9.3) 42.6  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 189 participants 387 participants
Female
171
  86.4%
170
  89.9%
341
  88.1%
Male
27
  13.6%
19
  10.1%
46
  11.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 189 participants 387 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%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 189 participants 387 participants
American Indian or Alaska Native
0
   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%
0
   0.0%
Black or African American
21
  10.6%
29
  15.3%
50
  12.9%
White
165
  83.3%
155
  82.0%
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%
0
   0.0%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 198 participants 189 participants 387 participants
35.2  (2.7) 35.5  (2.7) 35.4  (2.7)
1.Primary Outcome
Title Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 185 181
Least Squares Mean (Standard Error)
Unit of Measure: %TBL
6.86  (0.37) 3.59  (0.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Obalon Treatment Group, Sham Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0261
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Square Mean Difference
Estimated Value 3.28
Confidence Interval (2-Sided) 95%
2.24 to 4.32
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Subjects who received the Obalon Balloons.
Overall Number of Participants Analyzed 185
Measure Type: Count of Participants
Unit of Measure: Participants
120
  64.9%
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Exact Confidence Interval
Estimated Value 64.9
Confidence Interval (2-Sided) 95%
57.5 to 71.7
Estimation Comments [Not Specified]
3.Other Pre-specified Outcome
Title Percentage of Subjects With at Least 5% Total Body Loss: Obalon - Sham Group
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 185 181
Measure Type: Count of Participants
Unit of Measure: Participants
120
  64.9%
58
  32.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Obalon Treatment Group, Sham Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 32.8
Confidence Interval (2-Sided) 95%
23.1 to 42.5
Estimation Comments [Not Specified]
Time Frame Six months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treated Subjects Control Subjects
Hide 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 (%) Affected / at Risk (%)
Total   0/336 (0.00%)      0/359 (0.00%)    
Hide Serious Adverse Events
Treated Subjects Control Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/336 (2.08%)      5/359 (1.39%)    
Congenital, familial and genetic disorders     
Chiari Malformation  [1]  0/336 (0.00%)  0 1/359 (0.28%)  1
Gastrointestinal disorders     
Peptic ulcer disease  [2]  1/336 (0.30%)  1 0/359 (0.00%)  0
General disorders     
Heel Exostosis  [1]  0/336 (0.00%)  0 1/359 (0.28%)  1
Hepatobiliary disorders     
Cholelithiasis  [1]  2/336 (0.60%)  2 0/359 (0.00%)  0
Infections and infestations     
Pyelonephritis  [1]  0/336 (0.00%)  0 1/359 (0.28%)  1
Bacterial Meningitis  [1]  1/336 (0.30%)  1 0/359 (0.00%)  0
Wound Infection  [1]  0/336 (0.00%)  0 1/359 (0.28%)  1
Sepsis  [1]  0/336 (0.00%)  0 1/359 (0.28%)  1
Reproductive system and breast disorders     
Abnormal Pap Smear  [1]  1/336 (0.30%)  1 0/359 (0.00%)  0
Breast Cancer  [1]  1/336 (0.30%)  1 0/359 (0.00%)  0
Surgical and medical procedures     
Synovectomy  [1]  0/336 (0.00%)  0 1/359 (0.28%)  1
Knee Arthroplasty  [1]  1/336 (0.30%)  1 0/359 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
NOT Device or Procedure Related
[2]
Device or Procedure Related
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treated Subjects Control Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   321/336 (95.54%)      221/359 (61.56%)    
Gastrointestinal disorders     
Abdominal Pain  [1]  246/336 (73.21%)  501 51/359 (14.21%)  65
Nausea  [2]  191/336 (56.85%)  315 37/359 (10.31%)  43
Vomiting  [3]  61/336 (18.15%)  75 16/359 (4.46%)  16
Dyspepsia  [4]  60/336 (17.86%)  73 10/359 (2.79%)  11
Abdominal Distension  [5]  49/336 (14.58%)  54 10/359 (2.79%)  12
Eructation  [6]  31/336 (9.23%)  37 0/359 (0.00%)  0
Diarrhea  [7]  41/336 (12.20%)  47 15/359 (4.18%)  16
Gastric Irritation  [8]  24/336 (7.14%)  25 0/359 (0.00%)  0
Gastric Bleeding/Abrasion  [9]  17/336 (5.06%)  17 0/359 (0.00%)  0
Constipation  [10]  51/336 (15.18%)  57 37/359 (10.31%)  47
Infections and infestations     
Common Cold/Upper Respiratory Infection  [11]  46/336 (13.69%)  56 44/359 (12.26%)  50
Stomach/Seasonal Flu  [11]  29/336 (8.63%)  32 25/359 (6.96%)  28
Metabolism and nutrition disorders     
Headache/Migraine  [12]  22/336 (6.55%)  25 26/359 (7.24%)  30
Indicates events were collected by systematic assessment
[1]
Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 244/336 (76.62%) / 494 Events
[2]
Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 188/336 (55.95%) / 311 Events
[3]
Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 58/336 (17.26%) / 71 Events
[4]
Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 57/336 (16.96%) / 69 Events
[5]
Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 49/336 (14.58%) / 54 Events
[6]
Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 31/336 (9.23%) / 37 Events
[7]
Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 28/336 (8.33%) / 30 Events
[8]
Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 24/336 (7.14%) / 25 Events
[9]
Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 17/336 (5.06%) / 17 Events
[10]
Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 9/336 (2.68%) / 10 Events
[11]
Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 0/336 (0.00%) / 0 Events
[12]
Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 6/336 (1.79%) / 7 Events
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Amy VandenBerg, Vice-President, Clinical Affairs and Regulatory Affairs
Organization: Obalon Therapeutics, Inc.
Phone: 760.795.6551
EMail: avandenberg@obalon.com
Layout table for additonal information
Responsible Party: Obalon Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02235870    
Other Study ID Numbers: PTL-1100-0013
First Submitted: September 8, 2014
First Posted: September 10, 2014
Results First Submitted: June 28, 2017
Results First Posted: March 8, 2018
Last Update Posted: March 8, 2018