Back to resultsPrimary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Using Caiman® Technology (CAIMAN)
Primary Purpose
Ovarian Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Caiman® device
Sponsored by
About this trial
This is an interventional basic science trial for Ovarian Cancer focused on measuring Advanced ovarian cancer
Eligibility 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
Sites / Locations
- Catholic University of Sacred Heart Rome,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Caiman device
Arm Description
Time sparing and post-operative outcome in ovarian cancer including bowel resection for cytoreductive surgery with Caiman device
Outcomes
Primary Outcome Measures
time-sparing for bowel resection
Time needed for bowel resection and radical omentecomy in avanced ovarian cancer
Post surgical complications
F-up in 1-3 and 6 months with questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT03219242
First Posted
June 29, 2017
Last Updated
January 11, 2018
Sponsor
Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT03219242
Brief Title
Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Using Caiman® Technology
Acronym
CAIMAN
Official Title
Longitudinal Prospective Study on Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Patients Using Caiman® Technology
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2016 (Actual)
Primary Completion Date
July 1, 2016 (Actual)
Study Completion Date
January 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Longitudinal prospective study on primary debulking surgery including bowel resection in advanced stage ovarian cancer patients using Caiman® technology
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Advanced ovarian cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Caiman device
Arm Type
Experimental
Arm Description
Time sparing and post-operative outcome in ovarian cancer including bowel resection for cytoreductive surgery with Caiman device
Intervention Type
Device
Intervention Name(s)
Caiman® device
Intervention Description
Using CAIMAN device in primary surgery for ovarian cancer. Analyze potential time-sparing and the incidence of post-surgical complications.
Primary Outcome Measure Information:
Title
time-sparing for bowel resection
Description
Time needed for bowel resection and radical omentecomy in avanced ovarian cancer
Time Frame
up to 1 hour
Title
Post surgical complications
Description
F-up in 1-3 and 6 months with questionnaire
Time Frame
Up to 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Scambia, Professor
Organizational Affiliation
Catholic University of Sacred Heart
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University of Sacred Heart Rome,
City
Rome,
State/Province
Rome
ZIP/Postal Code
00100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Using Caiman® Technology
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