Teleassisted Surgery for Gynecological Disease in Obese Patients - OB-ALFX

Catholic University of the Sacred Heart

Status and phase: Unknown; Phase 2

Conditions: Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis

Treatments: Device: Telelap ALF-X

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02338505

21264/14

Details and patient eligibility

About

Phase II prospective single-institutional study.

Full description

The aim of this Phase II prospective single-institutional study is to assess feasibility and early complications rate of Telelap ALF-X surgical treatment in obese patients affected by gynecological disease.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Telelap ALF-X in obese patients with gynecological disease

Experimental group

Treatment:

Device: Telelap ALF-X