NCT03219242

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable ovarian-cancer

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable ovarian-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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 30, 2016

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 17, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

1 day

First QC Date

June 29, 2017

Last Update Submit

January 11, 2018

Conditions

Ovarian Cancer

Keywords

Advanced ovarian cancer

Outcome Measures

Primary Outcomes (2)

  • time-sparing for bowel resection

    Time needed for bowel resection and radical omentecomy in avanced ovarian cancer

    up to 1 hour

  • Post surgical complications

    F-up in 1-3 and 6 months with questionnaire

    Up to 6 months

Study Arms (1)

Caiman device

EXPERIMENTAL

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

Device: Caiman® device

Interventions

Caiman® deviceDEVICE

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

Caiman device

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or chronic infections
  • Previous pelvic radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Sacred Heart Rome,

Rome, Rome, 00100, Italy

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Giovanni Scambia, Professor

    Catholic University of Sacred Heart

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 17, 2017

Study Start

June 30, 2016

Primary Completion

July 1, 2016

Study Completion

January 30, 2018

Last Updated

January 16, 2018

Record last verified: 2018-01

Locations

IT(1)