Bariatric Surgery CandidateMRI pouchNCT06298162
Assessment of Pouch Emptying With MRI After Roux-en-Y Gastric Bypass
An observational study of Bariatric Surgery Candidate and Gastric Bypass, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
A cross-sectional observational study in which pouch emptying rate is measured with MRI in good (TWL>35%) and bad responders (TWL<25%) two years after Laparoscopic Roux-en-Y Gastric Bypass (LRYGB). Read more about this study
- Who is it for?
- Ages 20 to 55 years, women only
- Conditions the study is for
- Bariatric Surgery Candidate, Gastric Bypass, Obesity, Morbid
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Jul 2019to 1 Feb 2020
- 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 20 to 55 years
- Women only
- Adult
Study population: RYGB, with succesful (>35%) or unsuccesful (<25%) weight loss
Who may be able to join
- Women aged between 20 and 55 years
- Patients must be able to adhere to the study visit schedule and protocol requirements
- Patients must be able to give informed consent (IC) prior to any study procedures
- Patients who had a follow-up period up until two years after LRYGB and have successful or unsuccessful weight loss.
- Willing to be informed about incidental findings of pathology and approving of reporting this to their general physician
Who cannot join
- Diabetes Mellitus
- Menopausal
- Gastrointestinal problems, gastric or intestinal diseases
- Drug or alcohol addiction
- Inability to stop smoking during the overnight fasting period
- Pregnant or lactating
Show all 13Show fewer
- Having an intolerance or allergy for one of the components of the test product
- Inability to stop medications that affect gastrointestinal emptying like antisecretory drugs, narcotics and prokinetic agents
- Inability to stop medication that affects the motility of the upper gastrointestinal tract (anti-cholinergic drugs, prokinetics, theophylline, calcium blocking agents, opioids)
- Having a contra-indication to MRI scanning (including, but not limited to):
- Pacemakers and defibrillators
- Intraorbital or intraocular metallic fragments
- Ferromagnetic implants
Trial locations and contacts
1 site in 1 country.
About this study
A cross-sectional observational study in which pouch emptying rate is measured with MRI in good (TWL>35%) and bad responders (TWL<25%) two years after Laparoscopic Roux-en-Y Gastric Bypass (LRYGB).
- Being tested
- 2 years after RYGB, no intervention. MRI measurement. Observational.
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 years after RYGB, no intervention. MRI measurement. Observational.Other
no intervention. MRI measurement. Observation.
| Study group | Role | What they receive |
|---|---|---|
| RYGB, successful weight loss (TWL >35%) | TWL = total weight loss Receives: Other: 2 years after RYGB, no intervention. MRI measurement. Observational. | |
| RYGB, unsuccessful weight loss (TWL <25%) | Not described Receives: Other: 2 years after RYGB, no intervention. MRI measurement. Observational. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pouch emptying rate measured with MRI
Measured: Two years after LRYGB
Secondary outcomes (2)
subjective ratings of fullness
subjective ratings of fullness will be measured an a 100-unit Visual Analogue Scale
Measured: Two years after LRYGB
subjective ratings of wellbeing
subjective ratings of wellbeing will be measured an a 100-unit Visual Analogue Scale
Measured: Two years after LRYGB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start25 Jul 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298162
- Sponsor's protocol ID
- 2018-1279
- Acronym
- MRI pouch
- Status last verified
- Feb 2024
- First submitted
- 23 Jul 2021
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pouch Emptying With MRI After Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT06298162
- Acronym / sponsor ID
- MRI pouch / 2018-1279
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 7 Mar 2024 (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.
A cross-sectional observational study in which pouch emptying rate is measured with MRI in good (TWL>35%) and bad responders (TWL<25%) two years after Laparoscopic Roux-en-Y Gastric Bypass (LRYGB).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RYGB, successful weight loss (TWL >35%) | – | Other: 2 years after RYGB, no intervention. MRI measurement. Observational.TWL = total weight loss |
| RYGB, unsuccessful weight loss (TWL <25%) | – | Other: 2 years after RYGB, no intervention. MRI measurement. Observational. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- RYGB, with succesful (>35%) or unsuccesful (<25%) weight loss
Key inclusion criteria (5 listed)
- Women aged between 20 and 55 years
- Patients must be able to adhere to the study visit schedule and protocol requirements
- Patients must be able to give informed consent (IC) prior to any study procedures
- Patients who had a follow-up period up until two years after LRYGB and have successful or unsuccessful weight loss.
- Willing to be informed about incidental findings of pathology and approving of reporting this to their general physician
Key exclusion criteria (13 listed)
- Diabetes Mellitus
- Menopausal
- Gastrointestinal problems, gastric or intestinal diseases
- Drug or alcohol addiction
- Inability to stop smoking during the overnight fasting period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 years after RYGB, no intervention. MRI measurement. Observational.no intervention. MRI measurement. Observation. | Other | RYGB, successful weight loss (TWL >35%), RYGB, unsuccessful weight loss (TWL <25%) |
Primary outcome
Pouch emptying rate measured with MRI
Time frame: Two years after LRYGB
2 secondary outcomes
subjective ratings of fullness
Time frame: Two years after LRYGB
subjective ratings of wellbeing
Time frame: Two years after LRYGB
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and Gastric Bypass, run by Rijnstate Hospital at 1 site in Netherlands.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pouch emptying rate measured with MRI (time frame: Two years after LRYGB). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2024.