Examining Patterns in the Involvement of Gastric Bypass Patients in Clinical Studies

NCT05715892 | Not Yet Recruiting

• 1 other identifier: 80772648
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gastric Bypass; Weight Loss Surgery

Keywords

gastric bypass; weight loss surgery

Outcome Measures

Primary Outcomes (2)

• Number of patients who decide to participate in a gastric bypass clinical study

  3 months

• Rate of gastric bypass patients who remain until trial completion

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Gastric bypass patients who are actively considering participating in an observational clinical trial, but have not yet completed enrollment and randomization.

You may qualify if:

• Age 18 years and older
• Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention
• Capable of giving signed informed consent.

You may not qualify if:

• ECOG score of 4
• Ineligible for gastric bypass surgery
• Pregnant women or women actively seeking to become pregnant.

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• 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.

  PMID: 25105982 BACKGROUND

• Fisher BL, Barber AE. Gastric bypass procedures. Eur J Gastroenterol Hepatol. 1999 Feb;11(2):93-7. doi: 10.1097/00042737-199902000-00007.

  PMID: 10102217 BACKGROUND

• 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.

  PMID: 17938315 BACKGROUND

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

4159004227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 8, 2023
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: June 12, 2023

Record last verified: 2023-06