Phase 3 Bladder Cancer Trial, Recruiting NCT03216525 Sponsor: Brigham and Women's Hospital Condition: Bladder Cancer
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Phase 3 Bladder Cancer Trial, Recruiting

NCT03216525
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are scheduled to have your bladder fully removed and a new way of passing urine created, either through open surgery or using a robot-assisted approach.
  • You are between 18 and 85 years old.
  • Your overall health has been assessed by an anesthesiologist and rated as suitable for surgery (confirm with trial site).
  • Your new urinary system will use a section of your small intestine, either as a tube draining into a bag on your abdomen, or as a new internal pouch.
  • You are able to understand what the study involves, agree to take part, and have signed a consent form voluntarily.

Who may not be able to join:

  • You are only having part of your bladder removed, not the whole bladder.
  • You have previously had your entire colon, stomach, or part of your stomach removed, or you currently have a permanent colostomy or ileostomy bag.
  • You have taken more than three doses of opioid painkillers (by mouth or injection) in the seven days before surgery.
  • You have received chemotherapy for bladder cancer within one month before your scheduled surgery (note: chemotherapy given before this window to shrink the tumour is allowed).
  • You are pregnant, breastfeeding, or could become pregnant and are not using an approved form of birth control (confirm with trial site).
  • You have taken part in another clinical drug or device study within 30 days of your surgery, or plan to join another study at the same time as this one.
  • Your pre-screening blood or lab results show significant abnormalities that would lead to your surgery being cancelled (confirm with trial site).
  • You currently use illegal drugs or misuse alcohol.
  • You have a history of past surgeries, illnesses, or mental health conditions that the study team believes could affect the results or put you at additional risk (confirm with trial site).
  • You have severe dementia that affects your ability to carry out daily activities.
  • You have severe liver problems.
  • You have end-stage kidney disease.
  • You have heart failure.
  • You have a complete blockage of your digestive system.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Mark A Preston, MD, Brigham and Women's Hospital

Phone: 6175258274

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 October 2018
Est. completion
1 December 2023

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Time to Return of Bowel Function

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov