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

NCT ID: NCT03219242

Last Updated: 2018-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-01-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Caiman device

Time sparing and post-operative outcome in ovarian cancer including bowel resection for cytoreductive surgery with Caiman device

Group Type EXPERIMENTAL

Caiman® device

Intervention Type DEVICE

Using CAIMAN device in primary surgery for ovarian cancer. Analyze potential time-sparing and the incidence of post-surgical complications.

Interventions

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Caiman® device

Using CAIMAN device in primary surgery for ovarian cancer. Analyze potential time-sparing and the incidence of post-surgical complications.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Prof. Giovanni Scambia

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giovanni Scambia, Professor

Role: PRINCIPAL_INVESTIGATOR

Catholic University of Sacred Heart

Locations

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Catholic University of Sacred Heart Rome,

Rome, Rome, Italy

Site Status

Countries

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Italy

Other Identifiers

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25543/16

Identifier Type: -

Identifier Source: org_study_id

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