A Phase 3 clinical trial investigating the use of the PINPOINT imaging system in women with Ovarian Cancer reached its primary completion date on May 3, 2026. The study enrolled 310 participants to evaluate the system's impact on surgical outcomes.

Background

Ovarian cancer remains a significant challenge in oncology, often diagnosed at advanced stages, necessitating complex surgical interventions. A critical aspect of these surgeries involves resecting tumors and, when necessary, performing bowel anastomoses. Complications such as anastomotic leaks can significantly impact patient recovery and overall prognosis. Current intra-operative assessments rely on surgeon experience and visual cues, which may not always provide real-time, objective data on tissue viability. The PINPOINT endoscopic fluorescence imaging system aims to address this by offering a method to evaluate bowel blood flow in real-time using a special camera and a fluorescent dye, potentially allowing surgeons to identify and correct issues during the procedure itself.

Trial design

This Phase 3 study, titled "A Study of Intra-operative Imaging in Women With Ovarian Cancer," enrolled 310 participants with conditions including Ovarian Cancer and Ovarian Carcinoma. The trial's primary objective is to determine whether using the PINPOINT endoscopic fluorescence imaging system intra-operatively can reduce the risk of anastomotic leaks and other complications after ovarian cancer surgery. This intervention is being compared against standard intra-operative assessments alone.

What this means

The primary completion of this Phase 3 trial signifies that data collection for the study's main objectives has concluded. While specific results are not yet available, the completion marks a crucial step toward understanding the potential benefits of the PINPOINT imaging system in ovarian cancer surgery. If the system demonstrates efficacy in reducing complications like anastomotic leaks, it could offer a valuable tool for surgeons, potentially improving patient safety and recovery outcomes for individuals undergoing complex procedures for ovarian cancer.

Source

Information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The event for study NCT04878094 was recorded on 2026-05-03 on clinicaltrials.gov.