MastectomyRMRNCT04457167
Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Seconday Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.
A study testing Robot-assisted and Not robot-assisted surgery in people with Mastectomy and Breast Reconstruction, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastectomy, Breast Reconstruction
- What is being tested?
- Robot-assisted and Not robot-assisted surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2020to 1 Nov 2026
- 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
- Age ≥ 18 years old,
- Signed consent to participate,
- Women with breast cancer over 18 or at high risk of breast cancer (BRCA 1-2 mutations, PALB2, extensive border lesions)
- Mastectomy with conservation of the areolo-mammary plaque, or mastectomy without conservation of the areolo-mammary plaque and conservation of the skin case
- Mastectomy without conservation of the areolo-mammary plate, immediate breast reconstruction by prosthesis,
- immediate breast reconstruction by autologous latissimus dorsi flap
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- immediate breast reconstruction by latissimus dorsi flap and prosthesis,
- secondary breast reconstruction by latissimus dorsi flap
- Affiliation to, or beneficiary of, a social security scheme.
Who cannot join
- Patient under 18,
- Pregnant woman or likely to be (without effective contraception) or breastfeeding,
- Person in emergency situation, adult person subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or out of state to express his consent,
- Inability to submit to medical follow-up for the trial for geographic, social or psychological reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Secondary Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.
Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.
Read the detailed description
Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.
- Conditions
- Mastectomy, Breast Reconstruction
- Being tested
- Robot-assisted, Not robot-assisted surgery
- Keywords
- robot-assisted, mini-invasive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assistedDevice
robot-assisted surgery
Not robot-assisted surgeryProcedure or surgery
Not robot-assisted surgery
| Study group | Role | What they receive |
|---|---|---|
| Robotic surgery | Experimental | Robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap, Receives: Device: Robot-assisted |
| Non robotic surgery | Active comparator | Non-robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap, Receives: Procedure: Not robot-assisted surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of postoperative early complications
To assess the value of robotic surgery for breast mastectomy with preservation of the nipple-areola complex and immediate or delayed reconstruction by latissimus dorsi flap, with an evaluation of the rate of postoperative early complications (90 postoperative days)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Phase III, non-randomized, monocentric, observational, prospective trial.
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Houvenaeghel, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457167
- Sponsor's protocol ID
- RMR-IPC 2017-039
- Other IDs
- 2020-A01644-35
- Acronym
- RMR
- Status last verified
- Jun 2020
- First submitted
- 30 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Secondary Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.
- ClinicalTrials.gov ID
- NCT04457167
- Acronym / sponsor ID
- RMR / RMR-IPC 2017-039
- Conditions
- Mastectomy, Breast Reconstruction
- Keywords
- robot-assisted, mini-invasive surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 7 Jul 2020 (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.
Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.
Detailed description
Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase III, non-randomized, monocentric, observational, prospective trial.
| Arm | Type | Receives |
|---|---|---|
| Robotic surgery | Experimental | Device: Robot-assistedRobotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap, |
| Non robotic surgery | Active comparator | Procedure: Not robot-assisted surgeryNon-robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap, |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years old,
- Signed consent to participate,
- Women with breast cancer over 18 or at high risk of breast cancer (BRCA 1-2 mutations, PALB2, extensive border lesions)
- Mastectomy with conservation of the areolo-mammary plaque, or mastectomy without conservation of the areolo-mammary plaque and conservation of the skin case
- Mastectomy without conservation of the areolo-mammary plate, immediate breast reconstruction by prosthesis,
Key exclusion criteria (4 listed)
- Patient under 18,
- Pregnant woman or likely to be (without effective contraception) or breastfeeding,
- Person in emergency situation, adult person subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or out of state to express his consent,
- Inability to submit to medical follow-up for the trial for geographic, social or psychological reasons.
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 |
|---|---|---|
| Robot-assistedrobot-assisted surgery | Device | Robotic surgery |
| Not robot-assisted surgeryNot robot-assisted surgery | Procedure or surgery | Non robotic surgery |
Primary outcome
rate of postoperative early complications
Time frame: 90 days
To assess the value of robotic surgery for breast mastectomy with preservation of the nipple-areola complex and immediate or delayed reconstruction by latissimus dorsi flap, with an evaluation of the rate of postoperative early complications (90 postoperative days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Gilles Houvenaeghel principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted and Not robot-assisted surgery in people with Mastectomy and Breast Reconstruction, run by Institut Paoli-Calmettes 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 9 inclusion and 4 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 7 Jul 2020. 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 Dominique Genre (33491223778, DRCI.UP@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of postoperative early complications (time frame: 90 days). 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 7 Jul 2020.