Ovarian CancerCAIMANNCT03219242
Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Using Caiman® Technology
A study testing Caiman® device in people with Ovarian Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Longitudinal prospective study on primary debulking surgery including bowel resection in advanced stage ovarian cancer patients using Caiman® technology Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Caiman® device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jun 2016to 30 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or chronic infections
- Previous pelvic radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- Caiman® device
- Keywords
- Advanced ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caiman® deviceDevice
Using CAIMAN device in primary surgery for ovarian cancer. Analyze potential time-sparing and the incidence of post-surgical complications.
| Study group | Role | What they receive |
|---|---|---|
| Caiman device | Experimental | Time sparing and post-operative outcome in ovarian cancer including bowel resection for cytoreductive surgery with Caiman device Receives: Device: Caiman® device |
What is being measured
The primary outcome is the main question the study is designed to answer.
time-sparing for bowel resection
Time needed for bowel resection and radical omentecomy in avanced ovarian cancer
Measured: up to 1 hour
Post surgical complications
F-up in 1-3 and 6 months with questionnaire
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start30 Jun 2016
- Primary completion1 Jul 2016
- Study completion30 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Giovanni Scambia, Catholic University of the Sacred Heart
- Investigators
- Giovanni Scambia, Professor, Principal investigator, Catholic University of Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219242
- Sponsor's protocol ID
- 25543/16
- Acronym
- CAIMAN
- Status last verified
- Jan 2018
- First submitted
- 29 Jun 2017
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Prospective Study on Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Patients Using Caiman® Technology
- ClinicalTrials.gov ID
- NCT03219242
- Acronym / sponsor ID
- CAIMAN / 25543/16
- Conditions
- Ovarian Cancer
- Keywords
- Advanced ovarian cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 30 Jan 2018 (estimated)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caiman device | Experimental | Device: Caiman® deviceTime sparing and post-operative outcome in ovarian cancer including bowel resection for cytoreductive surgery with Caiman device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant or chronic infections
- Previous pelvic radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caiman® deviceUsing CAIMAN device in primary surgery for ovarian cancer. Analyze potential time-sparing and the incidence of post-surgical complications. | Device | Caiman device |
Primary outcome
time-sparing for bowel resection
Time frame: up to 1 hour
Time needed for bowel resection and radical omentecomy in avanced ovarian cancer
Post surgical complications
Time frame: Up to 6 months
F-up in 1-3 and 6 months with questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Scambia, Professor principal investigator
Catholic University of Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caiman® device in people with Ovarian Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time-sparing for bowel resection (time frame: up to 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.