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Pilot Study to Evaluate A Novel Gastric Space Occupying Device

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Obalon Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01444274
First received: September 28, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted

September 28, 2011
September 28, 2011
July 2011
September 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Pilot Study to Evaluate A Novel Gastric Space Occupying Device
A Single-Center 60-day Observational, Non-randomized Study to Evaluate Safety and Preliminary Efficacy of a Novel Gastric Space Occupying Device as an Aid for Weight Loss

This will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. No formal hypothesis testing will be conducted.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Overweight or obese individuals who have failed routine dieting in the past

Observational Study to Evaluate Weight Loss When Administering up to 2 Balloons Across the 60 Day Study Duration.
Device: Obalon Gastric Balloon(s)
One or two balloons administered per patient
Obalon Gastric Balloon
One or two balloons administered to each patient
Intervention: Device: Obalon Gastric Balloon(s)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age between 21-64 years
  2. BMI 27-40 Kg/m2
  3. No history of weight reduction of more than 5% of total body weight in the past 6 months

Exclusion Criteria:

  1. Have 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;
  2. Be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
  3. Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months;
  4. Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin;
  5. History or symptoms of thyroid disease which is not controlled by medication;
  6. Have severe renal, hepatic, pulmonary disease or cancer;
  7. Past history of gastrointestinal surgery (excluding uncomplicated appendectomy);
  8. Have a history of adhesive peritonitis;
  9. History or symptoms of esophageal and/or gastric varices;
  10. Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);
  11. History or symptoms of inflammatory bowel disease, such as Chron's disease;
  12. History of/ signs and /or symptoms of duodenal or gastric ulcer;
  13. Have gastroparesis;
  14. Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential);
  15. Currently using pharmaceutical agents for weight loss;
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01444274
PTL-1000-0012
No
Obalon Therapeutics, Inc.
Obalon Therapeutics, Inc.
Not Provided
Principal Investigator: Ariel Ortiz Lagardere, MD Obesity Control Center
Obalon Therapeutics, Inc.
September 2011

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