Gastric EmptyingEMRISSNCT06407193
Gastric Emptying After Sleeve Gastrectomy
An observational study of Gastric Emptying and Bariatric Surgery, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss [TWL] > 35%) and insufficient weight loss (TWL < 25%), better insight in the… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Gastric Emptying, Bariatric Surgery
- What is being tested?
- MRI and scintigraphy
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 May 2022to 30 Mar 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 to 55 years
- Women only
- Adult
Study population: Women after sleeve gastrectomy with either good or poor weight loss
Who may be able to join
- Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with either TWL < 25% or TWL > 35%.
- Patients who had a follow-up period of 2-3 years after sleeve gastrectomy
Who cannot join
- Maximum BMI >50 kg/m2
- Patients with a disease known to affect appetite, gastric emptying or gastrointestinal motility
- Patients who are unable to stop medications that affect gastric emptying and/or motility prior to measurements. It is depending on t1/2 for how long they need to stop medication
- Patients who started menopause
- Patients with gastrointestinal problems or, gastric or intestinal diseases
- Patients with a drug or alcohol addiction
Show all 10Show fewer
- Patients who are unable to stop smoking for 24h
- Patients who are pregnant or lactating
- Patients who have an intolerance or allergy for one of the components of the test product
- Patients who have a contra-indication to MRI scanning
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastric Emptying Measured With MRI and Scintigraphy in Patients With Successful Versus Unsuccessful Weight Loss After Sleeve Gastrectomy
Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss [TWL] > 35%) and insufficient weight loss (TWL < 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI.
Read the detailed description
Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. Patients' weight loss response on SG varies widely and is difficult to predict. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss [TWL] > 35%) and insufficient weight loss (TWL < 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI. MRI is a non-invasive imaging method which provides more detailed images of the SG compared to the conventionally used scintigraphy scans.
- Conditions
- Gastric Emptying, Bariatric Surgery
- Being tested
- MRI and scintigraphy
- Keywords
- Gastric emptying, Gastric sleeve, MRI, Scintigraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI and scintigraphyOther
Gastric emptying measured with MRI and scintigraphy
| Study group | Role | What they receive |
|---|---|---|
| Poor weight loss group | Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with TWL < 25% Receives: Other: MRI and scintigraphy | |
| Successful weight loss group | Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with TWL > 35% Receives: Other: MRI and scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying compared between patients with poor and successful weight loss
Gastric emptying (T1/2 [min] and retention [%/min])
Measured: 2-3 years
Gastric emptying compared between measured with MRI and scintigraphy
Gastric emptying (T1/2 [min] and retention [%/min])
Measured: 2-3 years
Secondary outcomes (3)
Sleeve characteristics compared between patients with successful and unsuccessful (poor) weight loss
Volume (sleeve size [mL] and gastric acid [mL])
Measured: 2-3 years
to assess the association between gastric emptying rate and gastric sleeve characteristics in each group
association between outcome 1, 2 and 3
Measured: 2-3 years
to compare subjective ratings of gastric fullness and wellbeing between patients with successful and unsuccessful weight loss
questionnaires (VAS-scale, MAIA, HADS, EBBS, Power of food scale, and Food tolerance test)
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start10 May 2022
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric EmptyingStudies 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
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University and Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407193
- Sponsor's protocol ID
- 2020-1690
- Acronym
- EMRISS
- Status last verified
- Mar 2026
- First submitted
- 25 Apr 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Emptying Measured With MRI and Scintigraphy in Patients With Successful Versus Unsuccessful Weight Loss After Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT06407193
- Acronym / sponsor ID
- EMRISS / 2020-1690
- Conditions
- Gastric Emptying, Bariatric Surgery
- Keywords
- Gastric emptying, Gastric sleeve, MRI, Scintigraphy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Wageningen University and Research
- Study start
- 10 May 2022 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 9 May 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.
Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss [TWL] > 35%) and insufficient weight loss (TWL < 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI.
Detailed description
Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. Patients' weight loss response on SG varies widely and is difficult to predict. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss [TWL] > 35%) and insufficient weight loss (TWL < 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI. MRI is a non-invasive imaging method which provides more detailed images of the SG compared to the conventionally used scintigraphy scans.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Poor weight loss group | – | Other: MRI and scintigraphyWomen aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with TWL < 25% |
| Successful weight loss group | – | Other: MRI and scintigraphyWomen aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with TWL > 35% |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women after sleeve gastrectomy with either good or poor weight loss
Key inclusion criteria (2 listed)
- Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with either TWL < 25% or TWL > 35%.
- Patients who had a follow-up period of 2-3 years after sleeve gastrectomy
Key exclusion criteria (10 listed)
- Maximum BMI >50 kg/m2
- Patients with a disease known to affect appetite, gastric emptying or gastrointestinal motility
- Patients who are unable to stop medications that affect gastric emptying and/or motility prior to measurements. It is depending on t1/2 for how long they need to stop medication
- Patients who started menopause
- Patients with gastrointestinal problems or, gastric or intestinal diseases
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 |
|---|---|---|
| MRI and scintigraphyGastric emptying measured with MRI and scintigraphy | Other | Poor weight loss group, Successful weight loss group |
Primary outcome
Gastric emptying compared between patients with poor and successful weight loss
Time frame: 2-3 years
Gastric emptying (T1/2 [min] and retention [%/min])
Gastric emptying compared between measured with MRI and scintigraphy
Time frame: 2-3 years
Gastric emptying (T1/2 [min] and retention [%/min])
3 secondary outcomes
Sleeve characteristics compared between patients with successful and unsuccessful (poor) weight loss
Time frame: 2-3 years
to assess the association between gastric emptying rate and gastric sleeve characteristics in each group
Time frame: 2-3 years
to compare subjective ratings of gastric fullness and wellbeing between patients with successful and unsuccessful weight loss
Time frame: 2-3 years
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 3 Apr 2026.
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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 Gastric Emptying and Bariatric Surgery, 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 2 inclusion and 10 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 3 Apr 2026. 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?
Gastric emptying compared between patients with poor and successful weight loss (time frame: 2-3 years). 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?
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 3 Apr 2026.