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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Obalon Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01718886
First received: October 29, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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


Condition Intervention
Obesity
Weight Control
Device: Obalon Gastric Balloon

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility Study to Evaluate Preliminary Safety and Efficacy of Multiple Obalon Gastric Balloons for 12 Weeks as an Aid for Weight Loss

Resource links provided by NLM:


Further study details as provided by Obalon Therapeutics, Inc.:

Primary Outcome Measures:
  • Percent Excess Weight Loss based on an ideal BMI of 25. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of all adverse events. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Obalon Gastric Balloon
Patients received 1-3 Obalon Gastric Balloons over a period of 12 weeks
Device: Obalon Gastric Balloon

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718886

Locations
Belgium
Department of Gastroenterology, Erasme Hospital
Brussels, Belgium, 6B1070
France
Service D'exploration Functionelle Digestive, Hospital Edouard Harriot
Lyon, Cedex, France, 69473
Sponsors and Collaborators
Obalon Therapeutics, Inc.
Investigators
Principal Investigator: Fancois Mion, MD Hospital Edouard Harriot
Principal Investigator: Jacques Deviere Erasme Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Obalon Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01718886     History of Changes
Other Study ID Numbers: PTL-1000-0018
Study First Received: October 29, 2012
Last Updated: October 29, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Obalon Therapeutics, Inc.:
Obesity
Weight loss
Weight control
Intragastric balloon
gastric balloon

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on April 15, 2014