TU-100 for Accelerating GI Recovery After Major Abdominopelvic Surgery (RC & CAWR) (NCT07765589) | Clinical Trial Compass
Not Yet RecruitingPhase 2
TU-100 for Accelerating GI Recovery After Major Abdominopelvic Surgery (RC & CAWR)
240 participantsStarted 2026-12
Plain-language summary
This Phase 2, multicenter, randomized, double-blind, placebo-controlled master protocol study will evaluate the safety and efficacy of TU-100, adjunctive to an Enhanced Recovery After Surgery (ERAS) pathway, for accelerating gastrointestinal recovery following major abdominopelvic surgery. TU-100 will be evaluated in 2 surgical populations under a Master Protocol: 1. Subjects undergoing Radical Cystectomy (RC), 2.subjects undergoing Complex Abdominal Wall Reconstruction (CAWR).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female participants aged 18 years or older
* American Society of Anesthesiologists (ASA) Physical Status Classification I-III
* Scheduled to undergo elective open or minimally invasive Radical Cystectomy (RC) with continent or incontinent urinary diversion requiring bowel resection, or open or complex minimally invasive surgery for Complex Abdominal Wall Reconstruction (CAWR) with anticipated myofascial advancement flap and mesh placement for moderate or giant hernia defects
* Body mass index (BMI) ≤40 kg/m²
* Women of childbearing potential and men with partners of childbearing potential must agree to use highly effective contraception
* Willing and able to comply with study procedures and able to voluntarily provide informed consent
Exclusion Criteria:
* Not scheduled for a Radical Cystectomy (RC) or Complex Abdominal Wall Reconstruction (CAWR) procedure meeting the inclusion criteria
* Known gastric or bowel obstruction
* Have had or have planned gastrectomy, gastric bypass, colostomy, or ileostomy
* Significant gastrointestinal motility disorders
* Pregnancy or breastfeeding
* Clinically significant hepatic, renal, cardiovascular, or other uncontrolled medical conditions
* Immunocompromised state or recent immunosuppressive therapy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Confirmed Gastrointestinal Recovery (GIR) Response by postoperative day (POD) 3
Timeframe: Postoperative Day 3
Trial details
NCT IDNCT07765589
SponsorTsumura USA
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-06
Contact for this trial
Tomoyuki Hashiguchi, Director, Clinical Development