Gynecological SurgeryNCT01953627
Laparoscopic Gynecologic Surgery With Robotic Assistance System Kymerax® : Pilot Study
A study testing Surgical procedure with the system Kymerax and The system Kymerax in people with Gynecological Surgery, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Laparoscopic robotic surgery (LSM) seems to increase quality of surgery. Diffusion of LSM is limited by cots of the only available system today. Kymerax® is a cheaper new system of LSM. Aim : To evaluate feasibility of laparoscopy with Kymerax® system in different laparoscopic procedures in gynecology. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecological Surgery
- What is being tested?
- Surgical procedure with the system Kymerax and The system Kymerax
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Dec 2014
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient requiring a following surgical procedure realized usually by coelioscopy:
- Total hysterectomy or inter annexielle for mild or neoplastic pathology Promontofixation for genital prolapse Annexectomie or ovarian kystectomie for ovarian pathology Pelvic or lombo-aortic cleaning out for uterine cancer Tubaire Salpingectomie for pathology Rectovaginale partition Exérèse hurts of endometriosis
Who cannot join
- Patient refusing to participate in the study
- Patient understanding French.
- Minor waits
Trial locations and contacts
1 site in 1 country.
aubert AGOSTINI contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
AUBERT AGOSTINI, aubert.agostini@ap-hm.fr
About this study
Laparoscopic robotic surgery (LSM) seems to increase quality of surgery. Diffusion of LSM is limited by cots of the only available system today. Kymerax® is a cheaper new system of LSM.
Aim : To evaluate feasibility of laparoscopy with Kymerax® system in different laparoscopic procedures in gynecology.
Material and methods : Observational study. Inclusion criteria were : patient requiring laparoscopic procedure in gynecology who give informed consent. The investigators evaluate procedures routinely performed by laparoscopy in gynecology.
Hypothesis : Procedures performed routinely in gynecology were feasible with Kymerax® system.
- Conditions
- Gynecological Surgery
- Being tested
- Surgical procedure with the system Kymerax, The system Kymerax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical procedure with the system KymeraxProcedure or surgery
The system KymeraxDevice
| Study group | Role | What they receive |
|---|---|---|
| Surgical procedure with the system Kymerax | Experimental | Not described Receives: Procedure: Surgical procedure with the system Kymerax; Device: The system Kymerax |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of Kymerax systemerax
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startOct 2012
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERNARD BELAIGUES, Study director, Assistance Publique Hopitaux De Marseilleaubert AGOSTINI, Principal investigator, AP HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953627
- Sponsor's protocol ID
- 2012-A00757-36
- Other IDs
- 2012-21
- Status last verified
- Jul 2014
- First submitted
- 24 Sep 2012
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Gynecologic Surgery With Robotic Assistance System Kymerax® : Pilot Study
- ClinicalTrials.gov ID
- NCT01953627
- Acronym / sponsor ID
- 2012-A00757-36
- Conditions
- Gynecological Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 1 Oct 2013 (estimated)
- 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.
Laparoscopic robotic surgery (LSM) seems to increase quality of surgery. Diffusion of LSM is limited by cots of the only available system today. Kymerax® is a cheaper new system of LSM.
Aim : To evaluate feasibility of laparoscopy with Kymerax® system in different laparoscopic procedures in gynecology.
Material and methods : Observational study. Inclusion criteria were : patient requiring laparoscopic procedure in gynecology who give informed consent. The investigators evaluate procedures routinely performed by laparoscopy in gynecology.
Hypothesis : Procedures performed routinely in gynecology were feasible with Kymerax® system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical procedure with the system Kymerax | Experimental | Procedure: Surgical procedure with the system Kymerax, Device: The system Kymerax |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient requiring a following surgical procedure realized usually by coelioscopy:
- Total hysterectomy or inter annexielle for mild or neoplastic pathology Promontofixation for genital prolapse Annexectomie or ovarian kystectomie for ovarian pathology Pelvic or lombo-aortic cleaning out for uterine cancer Tubaire Salpingectomie for pathology Rectovaginale partition Exérèse hurts of endometriosis
Key exclusion criteria (3 listed)
- Patient refusing to participate in the study
- Patient understanding French.
- Minor waits
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 |
|---|---|---|
| Surgical procedure with the system Kymerax | Procedure or surgery | Surgical procedure with the system Kymerax |
| The system Kymerax | Device | Surgical procedure with the system Kymerax |
Primary outcome
assessment of Kymerax systemerax
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
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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.
aubert AGOSTINI contact
BERNARD BELAIGUES study director
Assistance Publique Hopitaux De Marseille
aubert AGOSTINI principal investigator
AP HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical procedure with the system Kymerax and The system Kymerax in people with Gynecological Surgery, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 2 inclusion and 3 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 24 Jul 2014. 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 France. 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?
Contact aubert AGOSTINI (aubert.agostini@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of Kymerax systemerax (time frame: 18 months). 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 24 Jul 2014.