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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03219242
Recruitment Status : Unknown
Verified January 2018 by Prof. Giovanni Scambia, Catholic University of the Sacred Heart.
Recruitment status was:  Enrolling by invitation
First Posted : July 17, 2017
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Giovanni Scambia, Catholic University of the Sacred Heart

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Device: Caiman® device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Longitudinal Prospective Study on Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Patients Using Caiman® Technology
Actual Study Start Date : June 30, 2016
Actual Primary Completion Date : July 1, 2016
Estimated Study Completion Date : January 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

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.




Primary Outcome Measures :
  1. time-sparing for bowel resection [ Time Frame: up to 1 hour ]
    Time needed for bowel resection and radical omentecomy in avanced ovarian cancer

  2. Post surgical complications [ Time Frame: Up to 6 months ]
    F-up in 1-3 and 6 months with questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219242


Locations
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Italy
Catholic University of Sacred Heart Rome,
Rome,, Rome, Italy, 00100
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
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Principal Investigator: Giovanni Scambia, Professor Catholic University of Sacred Heart

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Responsible Party: Prof. Giovanni Scambia, Director, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT03219242    
Other Study ID Numbers: 25543/16
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

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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
Keywords provided by Prof. Giovanni Scambia, Catholic University of the Sacred Heart:
Advanced ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type