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NCT00026923 Clinical Trial

A Phase II Evaluation of Telesurgery Systems

Laparoscopy Clinical Trial

Official title:
A Phase II Evaluation of Telesurgery Systems

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00026923
Other study ID # 990028
Secondary ID 99-C-0028
Status Completed
Phase Phase 2
First received November 14, 2001
Last updated March 3, 2008
Start date January 1999
Est. completion date December 2001

Study information
Verified date December 2001
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Any patient undergoing laparoscopic surgery.

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic surgery

Locations
Country Name City State
United States National Cancer Institute (NCI) Bethesda Maryland

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

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