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NCT01237990 · 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
20
Enrollment target

NCT01237990: Completed study, sponsored by Pathfinder Therapeutics.

NCT01237990 is a clinical trial that has completed, run by Pathfinder Therapeutics. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01237990 has completed, sponsored by Pathfinder Therapeutics.

COMPLETED
Registry status
20 participants
Enrollment target

Study Summary

This study was designed to confirm that the surgeon is able to perform surface registration of standard liver features used as landmarks during a scheduled laparoscopic liver procedure. Additionally, registrations will be obtained with full insufflation pressure and with half insufflation pressure during the laparoscopic procedure. Under the presence of both insufflation pressures, 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 3D image. The surgeon will accept or reject the registration accuracy. Upon completion of the scheduled laparoscopic procedure, the subject will then undergo the open procedure scheduled for the surgical case. An open liver registration will be obtained with manual swabbing of the liver using the study tracked probe and will be accepted or rejected by the surgeon using the process described in the laparoscopic procedure. In the event that the disease is determined to be too great for surgical repair during the laparoscopic staging procedure, only minimally invasive liver surface data will be acquired and the patient will not be included in the overall study population.

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.

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2010-08
Est. Completion 2011-10
Pathfinder Therapeutics

5 total trials

What the finished NCT01237990 record still lists

NCT01237990 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.

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

NCT01237990 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01237990 about?

NCT01237990 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 surface registration of standard liver features used as landmarks during a scheduled laparoscopic liver procedure. Additionally, registrations will be obtained with full insufflation pressure and with half insufflation pressure d...

What is the current status of trial NCT01237990?

This trial is currently completed. The enrollment target is 20 participants. The study started on 2010-08. Estimated completion is 2011-10.

Who is sponsoring clinical trial NCT01237990?

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

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Source: ClinicalTrials.gov NCT01237990, the US trial registry maintained by the National Library of Medicine. NCT01237990 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.