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NCT06681831
Single-Port Hysterectomy (R-SPH) Using the Da Vinci SP System in Low-Risk Endometrial Cancer
NA trial testing DaVinci SP in Endometrial Cancer in 15 participants. Completed in 15 October 2024.
1 October 2024
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 26 June 2024 |
| Primary completion | 1 October 2024 |
| Estimated completion | 15 October 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- DaVinci SP
Conditions studied
- Endometrial Cancer — all drugs for Endometrial Cancer →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
Eligibility, female only, with Endometrial Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with clinically confirmed endometrioid endometrial cancer at FIGO stage IA-IB were eligible for robotic single-port hysterectomy (R-SPH). Criteria included: well or moderately differentiated tumor grade (G1 or G2), sufficient vaginal access, uterine size under 12 weeks' gestation, adequate bone marrow, kidney, liver, and heart function, and an ECOG performance status of 2 or below. Exclusions applied to patients with significant cardiopulmonary disease, previous pelvic or abdominal radiation, or severe hip disease affecting positioning. Prior abdominal surgeries did not exclude patients from robotic surgery. Surgeries were performed using the Vinci Single-Site® system by a specialized team. Clinical data collected included age, BMI, FIGO stage, tumor grade, surgical margin status, and hospital stay duration. Operation times were divided into docking, console (surgical), and total operation times. Intraoperative assessments included complications, blood loss, hemoglobin changes, and transfusions if hemoglobin was ≤7 g/L. Postoperative complications were evaluated short- and long-term, including surgical, cardiac, and respiratory events.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Feasibility, safety, and efficacy of robotic single-port hysterectomy (R-SPH) using the da Vinci SP system in low-risk endometrial cancer: a pilot study.
Vizza R, Corrado G, Mancini E, Baiocco E, et al · · 2025 · cited 4× · PMID 40788153 · DOI 10.1080/13645706.2025.2538764
Verify or expand the search:
- PubMed search for NCT06681831
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06681831 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 8 November 2024
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/NCT06681831.
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