Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-24 @ 1:18 PM
NCT ID:
NCT04502095
Eligibility Criteria:
Inclusion Criteria:
* Any patient that electively chooses to have a cystectomy is eligible to participate in the study. Indications for a person who may undergo a cystectomy include having a diagnosis of muscle-invasive bladder cancer (MIBC) or refractory non-muscle invasive bladder cancer (NMIBC)
* Any patient that will electively choose to have a robot-assisted radical cystectomy and is able to provide consent
* Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
* Patients with a history of myasthenia gravis
* Patients with a history of QT prolongation or taking other drugs that prolong corrected QTc (QTc) should be excluded
* Patients with renal dysfunction, creatinine clearance (mL/min) \< 30
* Pregnant or nursing female participants
* Females who receive a fertile sex sparing robot-assisted radical cystectomy (RARC)
* Unwilling or unable to follow protocol requirements
* Patients who receive a prophylactic antibiotic or antibiotic for any other reason prior to discharge
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04502095
Study Brief:
Protocol Section:
NCT04502095