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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: Obalon Gastric Balloon(s)

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Mexico
  • Baja California
    • Tijuana, Baja California, Mexico, 22320
      • Obesity Control Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obalon Gastric Balloon; One or two balloons administered to each patient	Device: Obalon Gastric Balloon(s); One or two balloons administered per patient

Collaborators and Investigators

• Sponsor: Obalon Therapeutics, Inc.
• Investigators: Principal Investigator: Ariel Ortiz Lagardere, MD, Obesity Control Center

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: September 28, 2011
• First Submitted That Met QC Criteria: September 28, 2011
• First Posted (Estimate): September 30, 2011

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PTL-1000-0012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No