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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03870269
Other study ID # 17-0904RP
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 25, 2019
Est. completion date September 30, 2022

Study information

Verified date July 2022
Source Ceevra, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A prospective, randomized, controlled study designed to assess whether digital virtual reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an improved understanding of their patients' anatomy, resulting in more efficient operations (robotic prostatectomy) and improved patient care.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient is undergoing robotic prostatectomy being performed by participating surgeon - Patient is willing to be randomized between intervention and control arms Exclusion Criteria: - Patients with prior pelvic radiation - Patients with prior androgen deprivation therapy - Patients with prior localized ablative therapy - Patients with prior TURP or other surgical BPH treatment

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ceevra Reveal
VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.

Locations

Country Name City State
United States UNC Hospital Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Ceevra, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total operative time During procedure, not to exceed 12 hours
Secondary Blood loss (measured in cubic centimeters) Measured at end of procedure, not to exceed 12 hours
Secondary Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure During procedure, not to exceed 12 hours
Secondary Intraoperative complication During procedure, not to exceed 12 hours
Secondary Patient hospital stay Measured at time of patient discharge, up to 10 days
Secondary Positive tumor margin (assessed via standard post-operative biopsy) Measured 1-2 weeks after discharge
Secondary Postoperative Gleason Score Measured up to 3 months after discharge
Secondary Postoperative oncologic stage (T stage) Measured up to 3 months after discharge
Secondary Readmission Measured up to 6 months after discharge
Secondary Postoperative prostate-specific antigen (PSA) Measured up to 12 months after disccharge
Secondary Postoperative erectile function Measured via survey up to 18 months after discharge
Secondary Postoperative continence Measured via survey up to 18 months after discharge
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