Trials / Not Yet Recruiting
Not Yet RecruitingNCT04457167
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.
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.
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 480 (estimated)
- Sponsor
- Institut Paoli-Calmettes · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Robot-assisted | robot-assisted surgery |
| PROCEDURE | Not robot-assisted surgery | Not robot-assisted surgery |
Timeline
- Start date
- 2020-11-01
- Primary completion
- 2023-11-01
- Completion
- 2026-11-01
- First posted
- 2020-07-07
- Last updated
- 2020-07-07
Locations
1 site across 1 country: France
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04457167. Inclusion in this directory is not an endorsement.