NCT02338505

Brief Summary

Phase II prospective single-institutional study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

January 12, 2015

Last Update Submit

January 13, 2015

Conditions

Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis

Keywords

Robotic SurgeryTelelap-ALFXGynecological disease

Outcome Measures

Primary Outcomes (1)

  • intraoperative complication rate

    Operative time, conversion rate, estimated blood loss, visceral injury

    intraoperative

Secondary Outcomes (1)

  • postoperative complication rate

    30 days

Study Arms (1)

Telelap ALF-X in obese patients with gynecological disease

EXPERIMENTAL
Device: Telelap ALF-X

Interventions

Telelap ALF-XDEVICE

Patients placed in the dorsal lithotomic position with both legs supported in Allen stirrups with a Trendelenburg tilt. After achieving pneumoperitoneum (12mmHg) through a trans umbilical open access technique, intra-abdominal visualization was obtained with a 10mm 0° HD 3D telescope. During the trocar placement the operative room nurses supported the surgeon in the docking procedures approaching the robotic arms to the operative table, in places established for pelvic surgery. The cockpit is located in one corner of our square shape room; the operative table is surrounded by the three robotic arms unit. Through the teleassisted operative ports we could make use of several type of instruments. Movements of both instruments and optic were completely carried out by the surgeon from the cockpit according to the needs of the procedure.

Also known as: ALF-X teleassisted surgery
Telelap ALF-X in obese patients with gynecological disease

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informed consent
  • ≤ 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

You may not qualify if:

  • Pregnancy
  • Liver disease
  • Coagulopathies
  • Clinical conditions contraindicating laparoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Sacred Heart Rome,

Rome, Rome, 00168, Italy

Location

Related Publications (4)

  • Gidaro 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: 23225591RESULT

  • Gidaro 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: 24706079RESULT

  • Lococo 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: 25225214RESULT

  • Falavolti 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: 25433265RESULT

Related Links

MeSH Terms

Conditions

Precancerous ConditionsGenital Diseases, Female

Condition Hierarchy (Ancestors)

NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Salvatore Gueli Alletti, MD

CONTACT

gueliallettis@gmail.com

Salvatore Gueli Alletti, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 14, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

IT(1)