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Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer

NCT04632251 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-11-17

No results posted yet for this study

Summary

This study is a prospective, open label, single-arm study to examine the performance and safety of the SENSEI® laparoscopic tethered gamma probe in patients undergoing 99mTc-nanocolloid SLNB for prostate cancer (PCa) during RP and ePLND surgery.

Patients scheduled for RP and ePLND using the standard treatment pathways at each centre will have preoperative 99mTc-nanocolloid imaging. RP and ePLND will be conducted as standard of care, with SLNB guided by the SENSEI® laparoscopic tethered gamma probe carried out after RP and prior to ePLND. The first 2 patients per site (N = 10 in total) are considered to be sufficient to enable further familiarisation with the procedure and use of the probe in addition to the usability work and training that the sites did prior to the start of this study. Subsequent patients will be evaluable for the PP population. The primary analysis of diagnostic performance will be performed using the PP population of patients with SLN identified on preoperative imaging

Conditions

Interventions

DEVICE

SENSEI®

SENSEI® laparoscopic tethered gamma probe is an intra-operative laparoscopic gamma probe system

Sponsors & Collaborators

  • Lightpoint Medical Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2021-02-16
Completion
2021-08-31

Countries

  • Belgium
  • France
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04632251 on ClinicalTrials.gov