A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05739162
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • Apollo Endoscopic Suture System — DEVICE
    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 Intervention — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Sep 20, 2023
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Endoscopic Sleeve Gastroplasty (ESG)
    Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention.

Primary Outcome Measure

Percent total body weight loss [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic MinnesotaRochesterMinnesota55905
Abigail A Stromme
[email protected]
507-538-8238

Find similar trials in Rochester, MN

By condition
Obesity / overweightUlcerative colitis
By specialty
EndocrinologyMetabolic healthWeight lossGastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Mayo Clinic Minnesota· Rochester, MN

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