NCT03130530

Brief Summary

The ALF-X (Advanced Laparoscopy through Force reflection) Robotic Surgery System is a medical device that is available for distribution in the EU (European Union) under CE Mark for use in general surgery, thoracic surgery, gynecological surgery and urological surgery. The main research question is to assess, from a retrospective poit of view, the safety and feasibility of this new robotic platform in the colorectal surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Status
completed

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

Study Start

First participant enrolled

June 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

April 19, 2017

Last Update Submit

April 21, 2017

Conditions

Colorectal Surgery

Keywords

roboticcolorectalsurgery

Outcome Measures

Primary Outcomes (1)

  • Evaluation adverse events

    Adverse events occurred during the surgery and during the 30 days after the surgery evaluated using Clavien-Dindo Classification, conversion rate to traditional laparoscopy or open surgery

    from the surgery up to 30 days after the surgery

Secondary Outcomes (5)

  • Duration of hospitalisation

    from surgery to hospital discharge, up to 30 days

  • Duration of surgery

    from to the start to the end of the surgery

  • Setup for surgery - collision rate

    from to the start to the end of the surgery

  • Setup for surgery - reduced mobility

    from to the start to the end of the surgery

  • Adverse events

    Up to 30 days post-surgery

Study Arms (1)

ALF-X

all patient underwent robotic colorectal surgery using ALF-X system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients indicated for colorectal surgery using ALF-X Robotic surgery system

You may qualify if:

  • Patients affected by colorectal disease (benign or malignant) having undergone surgery using ALF-X platform

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Antonino Spinelli, Prof.

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2017

First Posted

April 26, 2017

Study Start

June 1, 2015

Primary Completion

September 30, 2016

Study Completion

September 30, 2016

Last Updated

April 26, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share