A Phase II Evaluation of Telesurgery Systems - Full Text View

Purpose

This study evaluates a system of remote supervision of laparoscopic surgery. Laparoscopic surgery is performed through small holes in the abdomen called ports. A camera is passed through one port for visualization. Laparoscopic surgery requires an assistant to hold the camera and help the operating surgeon view the surgical field. The assistant camera holder may be a surgeon or a robotic arm. The robotic arm is usually controlled by the operating surgeon. In this study, a robotic arm holding the camera will be used, and will be controlled by a surgeon outside the operating room.

Condition	Intervention	Phase
Laparoscopy	Procedure: Laparoscopic surgery	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Primary Purpose: Treatment
Official Title:	A Phase II Evaluation of Telesurgery Systems

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	30
Study Start Date:	January 1999
Estimated Study Completion Date:	December 2001

Detailed Description:

This study evaluates a system of remote supervision of laparoscopic surgery. Laparoscopic surgery is performed through small holes in the abdomen called ports. A camera is passed through one port for visualization. Laparoscopic surgery requires an assistant to hold the camera and help the operating surgeon view the surgical field. The assistant camera holder may be a surgeon or a robotic arm. The robotic arm is usually controlled by the operating surgeon. In this study, a robotic arm holding the camera will be used, and will be controlled by a surgeon outside the operating room.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Any patient undergoing laparoscopic surgery.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026923

Locations

United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Cancer Institute (NCI)

More Information

Publications:

Kavoussi LR, Moore RG, Partin AW, Bender JS, Zenilman ME, Satava RM. Telerobotic assisted laparoscopic surgery: initial laboratory and clinical experience. Urology. 1994 Jul;44(1):15-9.

Moore RG, Adams JB, Partin AW, Docimo SG, Kavoussi LR. Telementoring of laparoscopic procedures: initial clinical experience. Surg Endosc. 1996 Feb;10(2):107-10.

Docimo SG, Moore RG, Adams J, Ben-Chaim J, Kavoussi LR. Early experience with telerobotic surgery in children. J Telemed Telecare. 1996;2 Suppl 1:48-50. No abstract available.

ClinicalTrials.gov Identifier:	NCT00026923 History of Changes
Other Study ID Numbers:	990028, 99-C-0028
Study First Received:	November 14, 2001
Last Updated:	March 3, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Laparoscopy
Telemedicine
Surgery
Endoscopy

ClinicalTrials.gov processed this record on May 19, 2013