Trial to Visualize the Ureters With Nizaracianine Triflutate in Adults Undergoing Abdominopelvic Surgery

Conditions

• Injury of Ureter During Surgery (Disorder)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nizaracianine Triflutate — DRUG
  Participants will receive up to 3 intravenous bolus injections with a minimal interval between doses of 60 minutes (surgeon discretion). Dose will be 1.0 or 2.5 mg depending on trial phase.
• Placebo Comparator — DRUG
  In Phase 3A only, \~50 subjects will be randomly allocated to receive sugar placebo

Study Details

The goal of this clinical trial is to determine if the drug Nizaracianine Triflutate can help surgeons see and avoid the ureters during abdominopelvic surgery. The ureters are thin-wall, collapsible tubes that connect the kidneys to the bladder. They are difficult to see during surgery and are sometimes damaged accidentally. The main questions to answer are: 1) is this drug safe for use in patients undergoing abdominopelvic surgery and 2) can the drug see the ureters while simultaneously providing information about how well they are working. The clinical trial has 3 parts. Surgery patients enrolled in the first part (Phase 2) will receive drug at different doses to determine the best dose. Patients enrolled in the second part (Phase 3A) will be randomly assigned to drug or placebo (sugar), at the best dose from Phase 2, so the two can be compared directly. Patients enrolled in the final part (Phase 3B) will all receive drug at the best dose from Phase 2.

Key Dates

Start date

Jun 28, 2024

Status verified

Feb 2026

Primary completion

Jul 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

336 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Nizaracianine Triflutate Study Drug Arm
  Participants will receive up to 3 intravenous bolus injections with a minimal interval between doses of 60 minutes (surgeon discretion). Dose will be 1.0 or 2.5 mg depending on trial phase.
• Placebo Comparator: Sugar Comparator Arm
  In Phase 3A only, \~50 subjects will be randomly allocated to receive sugar placebo.

Primary Outcome Measure

The fraction of subjects for whom the surgeon is able to successfully identify the required length of the ureters (specified by the surgeon at each timepoint), as verified by three independent blinded reviewers. [ Time Frame: 1 day (day of surgery) ]

Central Contacts

• Alexander L Vahrmeijer, M.D., Ph.D.
  +31 71 526 9111
  [email protected]
• Cedric Pesch, M.D.
  +31 71 526 9111
  [email protected]

Locations (5)

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