Pivotal Aspiration Therapy with Adjusted Lifestyle Study (PATHWAY)
Study Status
Open to Enrollment
Study Description
This is a study designed to test the safety of an investigational device called the AspireAssist Aspiration Therapy System, and to see if it can help people with obesity to lose weight.
Aspiration Therapy reduces the calories absorbed by the body, allowing a person to drain a portion of his/her stomach contents after a meal. The device includes:
- A silicone rubber tube (called the A-tube) that will run from the inside of the stomach to the skin surface of the abdomen, and
- A small flat valve called the Skin-Port, placed on the surface of the skin, to control the flow of stomach contents out of the tube.
Placement of the A-Tube will be performed as an outpatient endoscopic procedure (no overnight stay), using consious sedation. The procedure takes about 30 minutes and will be performed at NewYork-Presbyterian Hospital by the study gastroenterologist.
To perform Aspiration Therapy, about 20 minutes after eating each major meal of the day, participants will remove (aspirate) a portion of the food eaten by emptying the stomach contents. Because only about half the calories eaten are removed, the body still receives the calories it needs to function.
Study participants will be randomly assigned to one of two treatment groups:
- Aspiration Therapy Group: AspireAssist + Lifestyle Therapy
- Lifestyle Therapy Group: Lifestyle Therapy only
Participants have a two-thirds chance of being enrolled in the Aspriation Therapy Group and a one-third chance of being enrolled int he Lifestyle Therapy group. Participants in both groups will receive lifestyle therapy, which will include 10 sessions with a registered dietician.
The study will last for 1 year, during which there will be 14 to 16 visits, depending on the group. Participants enrolled in the Aspiration Therapy group will have the option of extending their participation to 5 years.
Participants will be compensated $75 for each visit, starting at the 2nd visit, and they will be compensated $125 for the year 1 visit.
Click here to learn more about the device and the trial and to watch a video.
Disease Status and/or Stage
Obesity
Sponsor
Aspire Bariatrics
Key Eligibility
- Men and women between the ages of 21 to 65
- Obese; Body Mass Index (BMI) 35-55
- Have failed attempt (for a duration equal to 3 months) to lose weight by alternative approaches (for example, supervised or unsupervised diets, exercise, behavioral modification programs)
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Louis Aronne, MD
Contact
- Comprehensive Weight Control Program
- (646) 962-2111 x38 Ask for the Research Department
- [email protected]
Healthy Volunteers
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
