ObesityNCT05739162
A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis
A study testing Apollo Endoscopic Suture System and Lifestyle Intervention in people with Obesity and Ulcerative Colitis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to gather information on the safety and effectiveness of Endoscopic Sleeve Gastroplasty (ESG) for weight loss in a population of obese UC patients undergoing colectomy with eventual IPAA. Read more about this study
- Who is it for?
- Ages 22 to 69 years
- Conditions the study is for
- Obesity, Ulcerative Colitis
- What is being tested?
- Apollo Endoscopic Suture System and Lifestyle Intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI 30-50 kg/m2 for at least 6 months prior to ESG
- Diagnosis of UC with plans to undergo or who have already undergone colectomy as part of a plan to pursue eventual 3-stage ileal pouch anal anastomosis (IPAA)
- Willing to adhere to the diet and behavior modifications required for ESG
- Able to follow the visit schedule
- Able to provide informed consent
- If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum Human Chorionic Gonadotropin (HCG) at screening/baseline
Who cannot join
- Prior gastric or bariatric surgery or other alteration to upper gastrointestinal anatomy which would preclude safe or technical performance of ESG
- Current or recent (last six months) gastric or duodenal ulceration
- Esophageal or gastric varices
- Significant motility disorder of the esophagus or stomach
- Large hiatal hernia measuring >5 cm or ≤ 5 cm and associated with severe gastroesophageal reflux
- Severe coagulopathy, hepatic insufficiency, or cirrhosis
Show all 16Show fewer
- Gastric mass
- Presence of any other medical condition which precludes safe performance of elective endoscopy such as poor general health and/or history of severe hepatic, cardiac, or pulmonary disease
- Serious or uncontrolled psychiatric illness which may compromise patient understanding of procedure or compliance with follow-up visits
- Unwilling to participate in an established diet and behavior modification program, with routine follow-up
- Ongoing corticosteroid use at a dose of >5 mg daily
- Daily use of anti-inflammatory agents such as non-steroidal medications, or anticoagulants without medical supervision
- Alcohol or drug addiction
- Females who are pregnant, nursing, or planning pregnancy within the next year
- Concomitant use of or unwillingness to avoid any use of weight loss medications, weight loss supplements, or weight loss herbal preparations
- Has a condition or is in a situation which in the investigator's opinion may put the subject at significant risk or may interfere significantly with the subject's participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Sleeve Gastroplasty (ESG) as a Treatment Option for Obesity in Ulcerative Colitis (UC) Patients Undergoing Colectomy With Ileal Pouch Anal Anastomosis (IPAA)
The purpose of this research is to gather information on the safety and effectiveness of Endoscopic Sleeve Gastroplasty (ESG) for weight loss in a population of obese UC patients undergoing colectomy with eventual IPAA.
- Conditions
- Obesity, Ulcerative Colitis
- Being tested
- Apollo Endoscopic Suture System, Lifestyle Intervention
- Keywords
- ESG, IPAA
- Medical subject headings
- Obesity, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apollo Endoscopic Suture SystemDevice
Endoscopic Sleeve Gastroplasty (ESG), and endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 70-80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall.
Lifestyle InterventionBehavioural
Low-calorie healthy diet personalized by a dietician according to individual patients' needs and conducive to weight loss. Physical activity will be encourage and assessed.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Sleeve Gastroplasty (ESG) | Experimental | Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention. Receives: Device: Apollo Endoscopic Suture System; Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Total Body Weight Loss
Percent total body weight loss (%TBWL) calculated by the equation ((baseline screening weight in kilograms (kg) subtracted by follow-up weight in kg) divided by baseline screening weight in kg) times 100.
Measured: 6 months
Number of Subjects With Serious Adverse Events
Total number of subjects to report serious adverse event related to the ESG procedure
Measured: 24 months
Secondary outcomes (5)
Number of Early Peri-operative Complications
Number of early (less than 30 days) peri-operative complications related to IPAA and ileostomy takedown clinical standard of care procedure
Measured: 1 year following procedure
Number of Late Peri-operative Complications
Number of late (greater than 30 days) peri-operative complications related to IPAA and ileostomy takedown clinical standard of care procedure
Measured: 1 year following procedure
Change Gastrointestinal Symptom Rating Scale (GSRS)
ESG tolerance measured by GSRS which includes 15 items and utilizes a 7-point response scale to measure a participant's level of discomfort associated with a given GI symptom, ranging from "No discomfort at all" to "Very severe discomfort."
Measured: Week 4, Week 12, Week 24, 12 months post-ileostomy takedown
Modified Pouchitis Disease Activity Index (mPDAI)
Assess overall pouch function one year following ileostomy takedown using the modified pouchitis disease activity index (mPDAI) score. The mPDAI quantitates clinical symptoms and endoscopic features (edema, granularity, friability, loss of vascular pattern, mucus exudate, and ulceration) on several separate 0-2 point scores, whereby a total score greater than or equal to 5 is indicative of pouchitis.
Measured: 12 months post-ileostomy takedown
Durable Weight Loss
Number of subjects to achieve durable weight loss
Measured: 12 months and 12 months post-ileostomy takedown
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start20 Sep 2023
- Primary completion1 Jul 2025
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda M. Johnson, Mayo Clinic
- Investigators
- Amanda M Johnson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739162
- Sponsor's protocol ID
- 22-007643
- Status last verified
- Jul 2026
- First submitted
- 13 Feb 2023
- Last updated
- 6 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Sleeve Gastroplasty (ESG) as a Treatment Option for Obesity in Ulcerative Colitis (UC) Patients Undergoing Colectomy With Ileal Pouch Anal Anastomosis (IPAA)
- ClinicalTrials.gov ID
- NCT05739162
- Acronym / sponsor ID
- 22-007643
- Conditions
- Obesity, Ulcerative Colitis
- Keywords
- ESG, IPAA
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Posted 6 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to gather information on the safety and effectiveness of Endoscopic Sleeve Gastroplasty (ESG) for weight loss in a population of obese UC patients undergoing colectomy with eventual IPAA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Sleeve Gastroplasty (ESG) | Experimental | Device: Apollo Endoscopic Suture System, Behavioral: Lifestyle InterventionParticipants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention. |
Who may qualify
- Ages
- 22 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI 30-50 kg/m2 for at least 6 months prior to ESG
- Diagnosis of UC with plans to undergo or who have already undergone colectomy as part of a plan to pursue eventual 3-stage ileal pouch anal anastomosis (IPAA)
- Willing to adhere to the diet and behavior modifications required for ESG
- Able to follow the visit schedule
- Able to provide informed consent
Key exclusion criteria (16 listed)
- Prior gastric or bariatric surgery or other alteration to upper gastrointestinal anatomy which would preclude safe or technical performance of ESG
- Current or recent (last six months) gastric or duodenal ulceration
- Esophageal or gastric varices
- Significant motility disorder of the esophagus or stomach
- Large hiatal hernia measuring >5 cm or ≤ 5 cm and associated with severe gastroesophageal reflux
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 |
|---|---|---|
| Apollo Endoscopic Suture SystemEndoscopic Sleeve Gastroplasty (ESG), and endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 70-80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall. | Device | Endoscopic Sleeve Gastroplasty (ESG) |
| Lifestyle InterventionLow-calorie healthy diet personalized by a dietician according to individual patients' needs and conducive to weight loss. Physical activity will be encourage and assessed. | Behavioural | Endoscopic Sleeve Gastroplasty (ESG) |
Primary outcome
Percent Total Body Weight Loss
Time frame: 6 months
Percent total body weight loss (%TBWL) calculated by the equation ((baseline screening weight in kilograms (kg) subtracted by follow-up weight in kg) divided by baseline screening weight in kg) times 100.
Number of Subjects With Serious Adverse Events
Time frame: 24 months
Total number of subjects to report serious adverse event related to the ESG procedure
5 secondary outcomes
Number of Early Peri-operative Complications
Time frame: 1 year following procedure
Number of Late Peri-operative Complications
Time frame: 1 year following procedure
Change Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Week 4, Week 12, Week 24, 12 months post-ileostomy takedown
Modified Pouchitis Disease Activity Index (mPDAI)
Time frame: 12 months post-ileostomy takedown
Durable Weight Loss
Time frame: 12 months and 12 months post-ileostomy takedown
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Amanda M Johnson, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apollo Endoscopic Suture System and Lifestyle Intervention in people with Obesity and Ulcerative Colitis, run by Mayo Clinic at 1 site in United States.
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 6 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Total Body Weight Loss (time frame: 6 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?
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 6 Aug 2026.