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NCT03517228

Pilot Trial of the Robotic Uterine Manipulator

Terminated NA Results posted Last updated 4 September 2024
What this trial tests

NA trial testing BAUM device in Gynecologic Surgery in 28 participants. Terminated before completion.

Timeline
24 April 2018
Primary endpoint
12 December 2023
12 December 2023

Quick facts

Lead sponsorMemorial Sloan Kettering Cancer Center
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment28
Start date24 April 2018
Primary completion12 December 2023
Estimated completion12 December 2023
Sites7 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, female only, with Gynecologic Surgery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

the Number of Intraoperative Complications Attributed to the Robotic Manipulator. Primary · 25- 35 days

will be assessed by reporting all intraoperative complications during the surgery. Complications might include vaginal tear or uterine perforation.

GroupValue95% CI
Total Laparoscopic or Robotic-assisted Hysterectomy0

Sponsor's own description

The purpose of this study is to test a robotic uterine manipulator system called the Barakat Automated Uterine Manipulator (BAUM), which will assist the surgeon in moving and positioning the uterus during a hysterectomy. This new device will allow the surgeon to control the movements of the robotic arm directly instead of giving verbal instructions to a staff member. The BAUM has never been used during surgeries before this trial. Overall, the study goal is to determine whether the use of this robotic uterine manipulator system can be safely used in the operating room while improving surgeon control during the procedure.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Gynecologic Surgery

Currently open trials in the same condition.

Other Memorial Sloan Kettering Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03517228.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing