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

NCT ID: NCT05715892

Last Updated: 2023-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-29

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Bypass Weight Loss Surgery

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Power Life Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Gill

Role: STUDY_DIRECTOR

Power Life Sciences Inc.

Central Contacts

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Michael B Gill

Role: CONTACT

4159004227

References

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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.

Reference Type BACKGROUND
PMID: 25105982 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 10102217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17938315 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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80772648

Identifier Type: -

Identifier Source: org_study_id

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