Pilot Study to Evaluate A Novel Gastric Space Occupying Device

NCT ID: NCT01444274

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-09-30

Brief Summary

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.

Conditions

Obesity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Obalon Gastric Balloon

One or two balloons administered to each patient

Obalon Gastric Balloon(s)

Intervention Type: DEVICE

One or two balloons administered per patient

Interventions

Obalon Gastric Balloon(s)

One or two balloons administered per patient

Intervention Type: DEVICE

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Obalon Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ariel Ortiz Lagardere, MD

Role: PRINCIPAL_INVESTIGATOR

Obesity Control Center

Locations

Obesity Control Center

Tijuana, Estado de Baja California, Mexico

Countries

Mexico

Other Identifiers

PTL-1000-0012

Identifier Type: -

Identifier Source: org_study_id