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NCT01238653 · ClinicalTrials.gov registry record

Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures

A clinical trial, sponsored by Pathfinder Therapeutics.

Terminated
Registry status
8
Enrollment target

NCT01238653: Clinical Trial study, sponsored by Pathfinder Therapeutics.

NCT01238653 is a clinical trial that was terminated before completion, run by Pathfinder Therapeutics. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01238653 was terminated before completion, sponsored by Pathfinder Therapeutics.

TERMINATED
Registry status
8 participants
Enrollment target

Study Summary

This study was 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 procedure. The hypothesis is that there will be no clinically relevant difference between the error measurements obtained during the laparoscopic procedures in this study when compared with those obtained during previous open liver registration studies. 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.

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 compared with open liver registrations obtained from previous validation studies during open liver procedures.

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2010-11
Est. Completion 2012-07
Pathfinder Therapeutics

5 total trials

Why NCT01238653 stopped before completion

NCT01238653 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01238653 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01238653 about?

NCT01238653 is a clinical study titled "Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures". This study was 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 procedure. The hypothesis is that there will be no clinically relevant difference between the error mea...

What is the current status of trial NCT01238653?

This trial is currently terminated. The enrollment target is 8 participants. The study started on 2010-11. Estimated completion is 2012-07.

Who is sponsoring clinical trial NCT01238653?

This trial is sponsored by Pathfinder Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01238653, the US trial registry maintained by the National Library of Medicine. NCT01238653 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.