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NCT01286428 · ClinicalTrials.gov registry record
Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures
A clinical trial, sponsored by Pathfinder Therapeutics.
- Completed
- Registry status
- 30
- Enrollment target
NCT01286428: Completed study, sponsored by Pathfinder Therapeutics.
NCT01286428 is a clinical trial that has completed, run by Pathfinder Therapeutics. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01286428 has completed, sponsored by Pathfinder Therapeutics.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study Summary
This study was designed in two phases: Phase I is designed to confirm that the surgeon is able to perform accurate liver surface registration including standard liver features used as landmarks during a scheduled laparoscopic liver ablation procedure and acquires a level of comfort with the procedure. The surface of the liver will be manually swabbed with the study tracked laparoscopic probe with landmarks noted during data collection. After registration of the liver is obtained, the registration points obtained during this procedure will be evaluated by the surgeon by moving the tracked laparoscopic probe over the liver surface and evaluating the location of the tracked laparoscopic probe displayed on the guidance system three dimensional (3D) image. The surgeon will accept or reject the registration accuracy. The hypothesis is that the surgeon will be able to successfully acquire liver surface registrations with a small learning curve for technique and will be able to proceed to Phase II of the study. Phase II contains the registration process included above but adds the additional process of tracking the ablation probe used to perform tumor ablation by attaching the Pathfinder Multi-Tool adaptor and collecting data showing the location of the ablation probe as tracked and displayed on the Pathfinder three dimensional (3D) image. The surgeon will use ultrasound (US) guidance to locate tumor location during the laparoscopic procedure. The images collected during this process will be recorded by Pathfinder.
Primary Outcome
Subjects are followed for the study 30days (+/- 14 days) and are considered to have completed the study following this 30 day follow-up visit. The performance of accurate physical-to-image registrations obtained during laparoscopic procedures will be evaluated and accepted by the surgeon during the procedure.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-03 |
What the finished NCT01286428 record still lists
NCT01286428 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01286428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01286428 about?
NCT01286428 is a clinical study titled "Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures". This study was designed in two phases: Phase I is designed to confirm that the surgeon is able to perform accurate liver surface registration including standard liver features used as landmarks during a scheduled laparoscopic liver ablation procedure and acquires a level of comfort with the procedur...
What is the current status of trial NCT01286428?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2011-01. Estimated completion is 2012-03.
Who is sponsoring clinical trial NCT01286428?
This trial is sponsored by Pathfinder Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
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