Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Using Caiman® Technology (CAIMAN)

January 11, 2018 updated by: Prof. Giovanni Scambia, Catholic University of the Sacred Heart

Longitudinal Prospective Study on Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Patients Using Caiman® Technology

Longitudinal prospective study on primary debulking surgery including bowel resection in advanced stage ovarian cancer patients using Caiman® technology

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Using CAIMAN® technology in primary surgery for advanced ovarian cancer including bowel resections.

Analyze potential time-sparing and the incidence of post-surgical complications.

Prospective, longitudinal, observational. 40 patients / year.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Rome
      • Rome,, Rome, Italy, 00100
        • Catholic University of Sacred Heart Rome,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age ≤ 75 years
  • Patients with advanced ovarian cancer (FIGO stage IIIC-IV).
  • Bowel resection
  • Class 0-2 according to the American Society of Anesthesiologists (i.e.: ASA score ≤ 2)
  • Written informed consent to the study

Exclusion Criteria:

  • Pregnant or chronic infections
  • Previous pelvic radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Caiman device
Time sparing and post-operative outcome in ovarian cancer including bowel resection for cytoreductive surgery with Caiman device
Device: Caiman® device
Using CAIMAN device in primary surgery for ovarian cancer. Analyze potential time-sparing and the incidence of post-surgical complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time-sparing for bowel resection
Time Frame: up to 1 hour
Time needed for bowel resection and radical omentecomy in avanced ovarian cancer
up to 1 hour
Post surgical complications
Time Frame: Up to 6 months
F-up in 1-3 and 6 months with questionnaire
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Investigators

  • Principal Investigator: Giovanni Scambia, Professor, Catholic University of Sacred Heart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Anticipated)

January 30, 2018

Study Registration Dates

First Submitted

June 29, 2017

First Submitted That Met QC Criteria

July 13, 2017

First Posted (Actual)

July 17, 2017

Study Record Updates

Last Update Posted (Actual)

January 16, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25543/16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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