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
  Purpose

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.


Condition Intervention
Observational Study to Evaluate Weight Loss When Administering up to 2 Balloons Across the 60 Day Study Duration.
Device: Obalon Gastric Balloon(s)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


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

Enrollment: 10
Study Start Date: July 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Obalon Gastric Balloon
One or two balloons administered to each patient
Device: Obalon Gastric Balloon(s)
One or two balloons administered per patient

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444274

Locations
Mexico
Obesity Control Center
Tijuana, Baja California, Mexico, 22320
Sponsors and Collaborators
Obalon Therapeutics, Inc.
Investigators
Principal Investigator: Ariel Ortiz Lagardere, MD Obesity Control Center
  More Information

No publications provided

Responsible Party: Obalon Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01444274     History of Changes
Other Study ID Numbers: PTL-1000-0012
Study First Received: September 28, 2011
Last Updated: September 28, 2011
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 14, 2014