Gastric Bypass Clinical Trial
Official title:
An Observational Study Investigating The Experiences of Patients In Gastric Bypass Clinical Trials
Clinical trial participation has historically been heavily biased toward specific demographics. Several people will be invited to enroll in this study so that it may collect a variety of data about gastric bypass clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal. The information collected from this study can be used to improve patient experience and outcomes for future patients and an opportunity to contribute to the advancement of medical knowledge and treatments for gastric bypass.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | February 2026 |
| Est. primary completion date | February 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Age 18 years and older - Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention - Capable of giving signed informed consent. Exclusion Criteria: - ECOG score of 4 - Ineligible for gastric bypass surgery - Pregnant women or women actively seeking to become pregnant. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
Collins BJ, Miyashita T, Schweitzer M, Magnuson T, Harmon JW. Gastric bypass: why Roux-en-Y? A review of experimental data. Arch Surg. 2007 Oct;142(10):1000-3; discussion 1004. doi: 10.1001/archsurg.142.10.1000. — View Citation
Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev. 2014 Aug 8;2014(8):CD003641. doi: 10.1002/14651858.CD003641.pub4. — View Citation
Fisher BL, Barber AE. Gastric bypass procedures. Eur J Gastroenterol Hepatol. 1999 Feb;11(2):93-7. doi: 10.1097/00042737-199902000-00007. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients who decide to participate in a gastric bypass clinical study | 3 months | ||
| Primary | Rate of gastric bypass patients who remain until trial completion | 12 months |
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|---|---|---|---|
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