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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014