Clinical trial · Interventional
Teleassisted Surgery for Gynecological Disease in Obese Patients - OB-ALFX
NCT02338505CI-TRIAL-00016614OB-ALFXunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase II prospective single-institutional study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Telelap ALF-X | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Telelap ALF-X in obese patients with gynecological disease
- interventionNames
- Device: Telelap ALF-X
Primary outcomes (1)
- measure
- intraoperative complication rate
- timeFrame
- intraoperative
- description
- Operative time, conversion rate, estimated blood loss, visceral injury
Secondary outcomes (1)
- measure
- postoperative complication rate
- timeFrame
- 30 days
- description
- Ileus, bleeding, infection/sepsi, thrombosis, rehospitalization, death
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * informed consent * 30 ≤ BMI \< 40 * ASA \< III * Ovarian Cyst * Prophylactic bilateral salpingo-oophorectomy * Ectopic Pregnancy * Pelvic Inflammatory Disease * Sterility/Infertility * Benign uterine disease (fibromatosis, adenomyosis) * Endometrial hiperplasia * Early-stage Endometrial Cancer * Preneoplastic lesions of the cervix * IA1 Cervical Cancer * Pelvic endometriosis Exclusion Criteria: * Pregnancy * Liver disease * Coagulopathies * Clinical conditions contraindicating laparoscopy
References
Publications (4)
- RESULTGidaro S, Buscarini M, Ruiz E, Stark M, Labruzzo A. Telelap Alf-X: a novel telesurgical system for the 21st century. Surg Technol Int. 2012 Dec;22:20-5. PMID 23225591
- RESULTGidaro S, Altobelli E, Falavolti C, Bove AM, Ruiz EM, Stark M, Ravasio G, Lazzaretti SS, Maurizio B. Vesicourethral anastomosis using a novel telesurgical system with haptic sensation, the Telelap Alf-X: a pilot study. Surg Technol Int. 2014 Mar;24:35-40. PMID 24706079
- RESULTLococo A, Larocca V, Marino F, De Filippis AF, Cesario A, Lococo F. Experimental Robotic Pulmonary Lobectomy With the TELELAP/ALFX System in the Ovine Model. Surg Innov. 2015 Jun;22(3):252-6. doi: 10.1177/1553350614549633. Epub 2014 Sep 15. PMID 25225214
- RESULTFalavolti C, Gidaro S, Ruiz E, Altobelli E, Stark M, Ravasio G, Ravasio G, Lazzaretti SS, Buscarini M. Experimental Nephrectomies Using a Novel Telesurgical System: (The Telelap ALF-X)-A Pilot Study. Surg Technol Int. 2014 Nov;25:37-41. PMID 25433265