VITOM Study: A Randomized, Controlled Trial.

NACompletedINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

March 31, 2018

Study Completion Date

December 31, 2018

Conditions
Pelvic Organ ProlapseProlapse of Vaginal Vault After HysterectomyBulging of Vaginal WallIncontinenceFistula
Interventions
OTHER

Live Surgery using VITOM

The vaginal operative field will be filmed with a VITOM® camera and the image from the VITOM® camera will be projected live within the operating room, so that the operating team can reference the image during the surgery.

OTHER

Live Surgery without VITOM

The vaginal operation will not be filmed and learner observation will take place in the traditional way, with them looking at the physical surgical field.

OTHER

Video viewing with VITOM

They will view the 10-minute standardized video filmed with the VITOM® camera.

OTHER

Video viewing with standard handheld high-definition camera

They will view the 10-minute standardized video filmed with the standard, handheld high-definition camera.

Trial Locations (1)

40202

Health Care Outpatient Center and University of Louisville, Louisville

Sponsors
All Listed Sponsors
collaborator

KARL STORZ Endoscopy-America, Inc.

INDUSTRY

lead

University of Louisville

OTHER

NCT03120689 - VITOM Study: A Randomized, Controlled Trial. | Biotech Hunter | Biotech Hunter