Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

European Study to Evaluate Preliminary Safety and Efficacy of Multiple Obalon Gastric Balloons for 12 Weeks as an Aid for Weight Loss

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: NCT01718886
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : October 31, 2012
Sponsor:
Information provided by (Responsible Party):
Obalon Therapeutics, Inc.

Tracking Information
First Submitted Date October 29, 2012
First Posted Date October 31, 2012
Last Update Posted Date October 31, 2012
Study Start Date January 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 29, 2012)
  • Percent Excess Weight Loss based on an ideal BMI of 25. [ Time Frame: 12 weeks ]
  • Assessment of all adverse events. [ Time Frame: 12 weeks ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title European Study to Evaluate Preliminary Safety and Efficacy of Multiple Obalon Gastric Balloons for 12 Weeks as an Aid for Weight Loss
Official Title Feasibility Study to Evaluate Preliminary Safety and Efficacy of Multiple Obalon Gastric Balloons for 12 Weeks as an Aid for Weight Loss
Brief Summary The objective of this study is to evaluate the initial safety and preliminary effectiveness of the Obalon intragastric balloon system in European subjects with a BMI in the range of 27 - 35 kg/m^2
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients were selected from investigators' patient population and included patients with a BMI in the range of 27 - 35 kg/m^2
Condition
  • Obesity
  • Weight Control
Intervention Device: Obalon Gastric Balloon
Study Groups/Cohorts Obalon Gastric Balloon
Patients received 1-3 Obalon Gastric Balloons over a period of 12 weeks
Intervention: Device: Obalon Gastric Balloon
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 Completed
Actual Enrollment
 (submitted: October 29, 2012)
17
Original Actual Enrollment Same as current
Actual Study Completion Date May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Were between 21-64 years of age;
  • Had a BMI 27-35 Kg/cm
  • Did not have a history of weight reduction over 5% of body weight over the past 6 months
  • Were able to comply with all study requirements for the duration of the study as outlined in the protocol. This included complying with the visit schedule as well as study specific procedures such as: electrocardiography, endoscopy, upper gastrointestinal radiography and clinical lab testing
  • Were able to understand and willing to provide written informed consent

Exclusion Criteria:

  • Experienced any difficulty in swallowing;
  • Had unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
  • Taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and not willingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
  • Taking blood pressure medications, unless their blood pressure was controlled and they have been at stable dose for at least 3 months;
  • Had type 1 diabetes or Type 2 diabetes requiring oral medications or insulin;
  • Had a history or symptoms of thyroid disease which is not controlled by medication;
  • Had severe renal, hepatic, pulmonary disease or cancer;
  • Had past history of gastrointestinal surgery (excluding uncomplicated appendectomy);
  • Had any abnormal stenosis or obstruction of the GI tract;
  • Had a history of adhesive peritonitis;
  • Had a previously diagnosed hiatal hernia greater than 2cm;
  • Had any abnormality of the esophagus, stomach or pylorus;
  • Had history of severe esophagitis;
  • Had history or symptoms of esophageal and/or gastric varices;
  • Had history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);
  • Had history or symptoms of inflammatory bowel disease, such as Chron's disease;
  • Had history of/ signs and /or symptoms of duodenal or gastric ulcer;
  • Untreated H.Pylori
  • Had history or signs of dysphasia, achalasia or symptoms of or GI motility;
  • Were undergoing chronic steroid or immunosuppressive therapy;
  • Were pregnant or breastfeeding or had the intention of becoming pregnant during the study;
  • Had placement of previous intragastric balloon or similar device;
  • Were using pharmaceutical agents for weight loss;
  • Were drinking alcohol in excess or using illicit drugs;
  • Had bulimia or binge eating disorders;
  • Had impending gastric surgery 30 days post balloon removal;
  • Had planned flying or scuba diving activities during balloon residence time;
  • Had any other condition that, in the opinion of the investigator, would interfere with their participation and compliance with the study (i.e. psychosocial issues);
  • Were participating in other investigational study protocols. If a subject had recently completed participation in another drug or device study, the subject must have completed that study at least 30 days prior to being enrolled in this study;
  • Had history or known allergies to any component of the device materials, including but not limited to allergies to porcine proteins.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 64 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01718886
Other Study ID Numbers PTL-1000-0018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Obalon Therapeutics, Inc.
Study Sponsor Obalon Therapeutics, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Fancois Mion, MD Hospital Edouard Harriot
Principal Investigator: Jacques Deviere Erasme hospital
PRS Account Obalon Therapeutics, Inc.
Verification Date October 2012