Clinical Trials
Clinical trials are scientific studies of how a new medicine or treatment works in people.
Why Participate?
The most common answer from our research participants is that they want to help others who are in their situation.
Participating in bariatric surgical research will provide more, and better, information to help:
- patients considering bariatric surgery make their decisions
- clinicians to provide the best possible care for their bariatric patients
We invite you to learn more about our current clinical trials on bariatric surgery to see if participating in this research is a good choice for you.
Please note that additional inclusion and exclusion criteria apply. Contact the study coordinator for more details.
Current Clinical Trials on Bariatric Surgery
StomaphyX versus Sham — test of a device to help reduce regain weight after bariatric surgery
| Who can participate |
Currently closed to enrollment |
| Who can't participate |
Patients who have had revisional surgery after RNYGB. Patients with an anatomic condition precluding passage of the StomaphyX device. |
| What we'll study |
- This study will help determine if an investigational device — called StomaphyX — can reduce the amount of regained weight after bariatric surgery and weight loss.
- The StomaphyX device is a surgical tool that is inserted through the mouth and into the stomach, to make the pouch smaller and reduce the quantity of food that can be eaten at each meal.
- The study will observe weight and health changes in participants for one year after treatment.
|
| How we'll conduct the study |
Participants will be randomly assigned to one of two treatment groups:
- StomaphyX
- Sham (control)
|
| Who to contact |
If you’re interested in participating in this clinical study, or want to learn more, please call 412-641-3632. |
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Triabetes Study — test to compare medical and surgical treatments for Type 2 Diabetes
| Who can participate |
Currently closed to enrollment |
| Who can't participate |
Patients who have had prior bariatric or foregut surgery, who are current smokers and who are unable to exercise (walk a city block or climb a flight of stairs). |
| What we'll study |
- The many unanswered questions about the best treatment for Type 2 Diabetes in patients with mild to moderate obesity.
- Whether diabetes is influenced by the type of surgery or by the amount of weight lost, or if bariatric surgery is more effective than non-surgical weight loss induced by diet and physical activity.
- The effectiveness of various bariatric surgery procedures versus an intensive behavioral intervention to induce weight loss with diet and increased physical activity.
- The feasibility of performing this type of randomized trial.
|
| How we'll conduct the study |
Participants will be randomly assigned to one of three treatment arms:
- gastric bypass
- gastric banding
- structured weight loss program
|
| Who to contact |
If you’re interested in participating in this clinical study, or want to learn more, please call 412-641-3743 or e-mail eagletonjk@upmc.edu. |
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Safety and Effectiveness of Allergan’s BioEnterics® Intragastric Balloon (BIBTM) System — test of the safety and efficacy of balloon placed into the stomach for weight loss
| Who can participate |
Currently closed to enrollment |
| What we'll study |
- This study will evaluate the safety and effectiveness of the BIBTM System — a non-surgical, non-pharmaceutical, investigational device for the treatment of obesity — in comparison to a behavioral modification program in obese patients.
- Changes in weight, BMI, obesity-related comorbidities, and quality of life will be assessed.
|
| How we'll conduct the study |
Participants will be randomly assigned to one of two treatment groups:
- the balloon placement group
- the control group
All participants will receive a 52-week behavioral modification program. |
| Who to contact |
If you’re interested in participating in this clinical study, or want to learn more, please call 412-641-3632. |
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