will be assessed by reporting all intraoperative complications during the surgery. Complications might include vaginal tear or uterine perforation.
| Group | Value | 95% CI |
|---|---|---|
| Total Laparoscopic or Robotic-assisted Hysterectomy | 0 |
Last reviewed · How we verify
Pilot Trial of the Robotic Uterine Manipulator
NA trial testing BAUM device in Gynecologic Surgery in 28 participants. Terminated before completion.
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 24 April 2018 |
| Primary completion | 12 December 2023 |
| Estimated completion | 12 December 2023 |
| Sites | 7 locations across United States |
Memorial Sloan Kettering Cancer Center — full company profile →
18 and older, female only, with Gynecologic Surgery. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
will be assessed by reporting all intraoperative complications during the surgery. Complications might include vaginal tear or uterine perforation.
| Group | Value | 95% CI |
|---|---|---|
| Total Laparoscopic or Robotic-assisted Hysterectomy | 0 |
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.
No peer-reviewed publications indexed yet for this trial.
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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