Clincosm LogoSign in Get a demo

PAS: Obalon Balloon System Post-Approval Study

Sponsor
Obalon Therapeutics, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03570034
Collaborator
(none)
201
Enrollment
15
Locations
32.9
Anticipated Duration (Months)
13.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Obalon Balloon System - Post-Approval Study is a prospective, observational, and multi-center study.

Condition or Disease Intervention/Treatment Phase
  • Device: Obalon Balloon System

Detailed Description

The Obalon PAS is a 1-year study that includes 6-month of Obalon Balloon therapy in conjunction of a weight loss behavior modification (WLBM) program and 6-month of continued WLBM program after balloon removal

Study Design

Study Type:
Observational
Actual Enrollment :
201 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Obalon Balloon System - Post-Approval Study
Actual Study Start Date :
Jun 15, 2018
Anticipated Primary Completion Date :
Sep 13, 2020
Anticipated Study Completion Date :
Mar 13, 2021

Arms and Interventions

Arm Intervention/Treatment
Obalon Balloon System

Obalon Balloon System with moderate intensity Weight Loss Behavioral Modification Program

Device: Obalon Balloon System
Obalon Balloon System with a moderate intensity Weight Loss Behavioral Modification Program

Outcome Measures

Primary Outcome Measures

  1. Serious Adverse Event [6-Month]

    Device or Procedure related Serious Adverse Event

  2. Percentage of Patients with at least 5% TBWL [6-Month]

    Percentage of Patients with at least 5% TBWL

  3. Mean % TBWL [6-Month]

    Mean %TBWL

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • At least 22 years old

  • BMI of 30-40 kg/m2

Exclusion Criteria:

  • Contraindicated for the device

  • Use of medications or medical devices known to induce weight gain or weight loss within the preceding 6 months.

  • Known history of endocrine disorders affecting weight.

  • Participation in any clinical study which could affect weight loss within the past year

  • Known history or present condition of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract, including, Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, diverticula, or any other disorder of the esophagus

  • Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator

Contacts and Locations

Locations

Site City State Country Postal Code
1 Smart Dimensions Weight Loss Fountain Valley California United States 92694
2 Davtyan Medical Weight Loss and Wellness Glendale California United States 91202
3 Lifetime Surgical Weight Loss Los Gatos California United States 95032
4 SkyLex Health Santa Monica California United States 90404
5 University of Colorado Denver Aurora Colorado United States 80045
6 Surgical Specialists of Louisiana Metairie Louisiana United States 70001
7 New Jersey Bariatric Center Springfield New Jersey United States 07081
8 Greenwich Village Gastroenterology Poughkeepsie New York United States 12601
9 New York Bariatric Group Roslyn Heights New York United States 11577
10 JourneyLite Physicians Cincinnati Ohio United States 45241
11 Artisan Cosmetic Surgery Toledo Ohio United States 43617
12 Minimally Invasive Surgical Associates Dallas Texas United States 75208
13 Snow Bariatic Center Flower Mound Texas United States 75028
14 Ultimate Bariatrics Fort Worth Texas United States 76102
15 Bariatric Medical Institute of Texas San Antonio Texas United States 78258

Sponsors and Collaborators

  • Obalon Therapeutics, Inc.

Investigators

  • Principal Investigator: Shelby Sullivan, MD, FACG, University of Colorado, Denver
  • Principal Investigator: Rachel Moore, MD, FACS, FASMBS, Surgical Specialist of Louisiana

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Obalon Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT03570034
Other Study ID Numbers:
  • PTL-7500-0011
First Posted:
Jun 26, 2018
Last Update Posted:
Apr 30, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes

Study Results

No Results Posted as of Apr 30, 2020