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

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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.

Tracking Information
First Submitted Date  ICMJE September 8, 2014
First Posted Date  ICMJE September 10, 2014
Results First Submitted Date  ICMJE June 28, 2017
Results First Posted Date  ICMJE March 8, 2018
Last Update Posted Date March 8, 2018
Study Start Date  ICMJE February 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2018)
  • Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups [ Time Frame: 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
  • Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL) [ Time Frame: 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%
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT02235870 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: February 6, 2018)
Percentage of Subjects With at Least 5% Total Body Loss: Obalon - Sham Group [ Time Frame: 6 Months ]
Difference in percentage of subjects between the Obalon Treatment and Sham Control groups with at least 5% Total Body Loss (TBL)
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Obalon Balloon System Pivotal IDE (SMART) Trial
Official Title  ICMJE The Six-Month Adjunctive Weight Reduction Therapy (SMART) Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Device: Obalon Intragastric Balloons
    Intragastric Balloon System to aid in portion control.
  • Device: Sham Device
    Sham Intragastric Balloon
  • Behavioral: Nutrition and Lifestyle Program
    Nutrition and lifestyle program reviewed with subjects every 3 weeks for 6 months.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Obalon Intragastric Balloons
    • Behavioral: Nutrition and Lifestyle Program
  • 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.
    Interventions:
    • Device: Sham Device
    • Behavioral: Nutrition and Lifestyle Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2016)
711
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02235870
Other Study ID Numbers  ICMJE PTL-1100-0013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Obalon Therapeutics, Inc.
Study Sponsor  ICMJE Obalon Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Amy VandenBerg Obalon Therapeutics, Inc.
PRS Account Obalon Therapeutics, Inc.
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP