Cure8 trial brief
Why This Matters
Weight loss before or around colectomy/IPAA could affect surgical risk and recovery; this study tests an endoscopic, non‑surgical weight‑loss procedure specifically in people with ulcerative colitis who are planning pouch surgery.
It may be of interest to patients and clinicians exploring safe ways to lose weight before complex bowel surgery.
Who Should Pay Attention
Adult UC patients who are obese and planning colectomy/IPAA; colorectal surgeons; gastroenterologists; dietitians; clinical researchers in IBD and bariatric/endoscopic procedures.
Study Snapshot
What To Know
This is a ClinicalTrials.gov record for an interventional study testing Endoscopic Sleeve Gastroplasty (ESG) using the Apollo Endoscopic Suture System in patients with obesity and ulcerative colitis who are undergoing or planning colectomy with eventual ileal pouch-anal anastomosis (IPAA).
The study will pair the ESG procedure with a post-procedure lifestyle intervention (personalized low-calorie diet and encouraged physical activity). Primary outcomes include percent total body weight loss at 6 months and number of subjects with serious adverse events related to ESG over 24 months.
Eligibility limits participants to adults (22–69 years) with BMI 30–50 kg/m2 and specific surgical plans; multiple GI and medical exclusion criteria are listed. The record describes the ESG technique (endoscopically placed full-thickness sutures to reduce gastric volume by ~70–80%) and the study setting at Mayo Clinic Rochester.
The registry status is ACTIVE_NOT_RECRUITING and planned enrollment is small (registry text states 2), so this appears to be an early/small interventional feasibility/safety study.
Keep In Mind
This is a ClinicalTrials.gov interventional trial record from Mayo Clinic describing the planned procedure, eligibility, and outcomes. It is not a results report; planned enrollment appears very small. ESG is described as an endoscopic suturing procedure to reduce stomach volume; the trial combines ESG with diet/behavior interventions.
Source Details
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.