Gastric BypassNCT05715892
Examining Patterns in the Involvement of Gastric Bypass Patients in Clinical Studies
An observational study of Gastric Bypass and Weight Loss Surgery, run by Power Life Sciences Inc..
Trial 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'… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Bypass, Weight Loss Surgery
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gastric bypass patients who are actively considering participating in an observational clinical trial, but have not yet completed enrollment and randomization.
Who may be able to join
- Age 18 years and older
- Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention
- Capable of giving signed informed consent.
Who cannot join
- ECOG score of 4
- Ineligible for gastric bypass surgery
- Pregnant women or women actively seeking to become pregnant.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Gastric Bypass, Weight Loss Surgery
- Keywords
- gastric bypass, weight loss surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who decide to participate in a gastric bypass clinical study
Measured: 3 months
Rate of gastric bypass patients who remain until trial completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study startFeb 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric BypassStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715892
- Sponsor's protocol ID
- 80772648
- Status last verified
- Jun 2023
- First submitted
- 27 Jan 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25105982Fisher BL, Barber AE. Gastric bypass procedures. Eur J Gastroenterol Hepatol. 1999 Feb;11(2):93-7. doi: 10.1097/00042737-199902000-00007.
PubMed 10102217Collins 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.
PubMed 17938315
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Investigating The Experiences of Patients In Gastric Bypass Clinical Trials
- ClinicalTrials.gov ID
- NCT05715892
- Acronym / sponsor ID
- 80772648
- Conditions
- Gastric Bypass, Weight Loss Surgery
- Keywords
- gastric bypass, weight loss surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gastric bypass patients who are actively considering participating in an observational clinical trial, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Age 18 years and older
- Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention
- Capable of giving signed informed consent.
Key exclusion criteria (3 listed)
- ECOG score of 4
- Ineligible for gastric bypass surgery
- Pregnant women or women actively seeking to become pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients who decide to participate in a gastric bypass clinical study
Time frame: 3 months
Rate of gastric bypass patients who remain until trial completion
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Background: PubMed 25105982Colquitt 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.
- Background: PubMed 10102217Fisher BL, Barber AE. Gastric bypass procedures. Eur J Gastroenterol Hepatol. 1999 Feb;11(2):93-7. doi: 10.1097/00042737-199902000-00007.
- Background: PubMed 17938315Collins 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Gill study director
Power Life Sciences Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Bypass and Weight Loss Surgery, run by Power Life Sciences Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (4159004227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who decide to participate in a gastric bypass clinical study (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05715892, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.