Genetic PredispositionMRIMOPNCT03838549
Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication
A study testing Prophylactic mastectomy with immediate breast reconstruction in people with Genetic Predisposition and Breast Cancer, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Genetic Predisposition, Breast Cancer
- What is being tested?
- Prophylactic mastectomy with immediate breast reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2019to 26 Sep 2025
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with an indication for prophylactic uni or bilateral mastectomy (Genetic risk factors for breast cancer)
- Ask an immediate breast reconstruction during the surgery
- World Heath Organization score <3
- Glandular volume : french bra cup size A, B ou C
- Glandular ptosis <=2 (Classification and Algorithm for Treatment of Breast Ptosis)
- Contraception for woman of childbearing age and no pregnancy
- Valid Social Security
- Wrote consent
Who cannot join
- History of breast cancer surgery
- Breast cancer not operated on the side concerned by the prophylactic mastectomy
- Patient having had irradiant treatment
- Breast hypertrophy
- Smoking > 10 cigarette/day
- Body Mass Index > 30
Show all 15Show fewer
- Large breast volume requiring prostheses > 500ml
- Chronic pulmonary obstructive gold 4
- ASA (Physical Status score of American Society of Anesthesiologists) > 3
- Chronic shoulder pain on the side to operate, or both shoulders
- History of abarticular pathology of the shoulder on the operating side
- Patient involvment in another clinical research
- Protected patient or unable to give consent
- Pregnant or breastfeeding woman
- Vulnerable person (Article L1121-6 of the Public Health Code)
Trial locations and contacts
1 site in 1 country.
About this study
Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume. Current techniques involve partial or total coverage of the implant with the pectoralis major muscle, to prevent exposure or infection. The muscle dissection technique applied has functional and cosmetic consequences. In this study, an endoscopic approach will be evaluated. This new surgical technique, using a single-port endoscopic way, will put the scar is in the axillary area, away from the breast. The hypothesis is that this delocalized scar potentially reduces the risk of exposure and allows placement of the implant in the subcutaneous space, with no manipulation of the pectoralis major muscle.
Read the detailed description
It s a practicability study, evaluating endoscopic approach for prophylactic mastectomy, using an axillary single port. Classic open surgery conversion rate, operative time, infectious rate, esthetical outcomes, and functional outcomes will be evaluated.
- Conditions
- Genetic Predisposition, Breast Cancer
- Being tested
- Prophylactic mastectomy with immediate breast reconstruction
- Keywords
- Prophylactic Surgical Procedure, Subcutaneous Mastectomy, Endoscopy, Breast Reconstruction, Breast Implants
- Medical subject headings
- Genetic Predisposition to Disease, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic mastectomy with immediate breast reconstructionProcedure or surgery
It is an endoscopic approach for prophylactic mastectomy using an axillary single port
| Study group | Role | What they receive |
|---|---|---|
| implant for breast reconstruction | Experimental | 20 patients female with genetic risk for breast cancer and who ask for prophylactic mastectomy. They will have a prophylactic mastectomy with immediate breast reconstruction Receives: Procedure: Prophylactic mastectomy with immediate breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of total mastectomy
The total mastectomy is done by a scar in the axillary area, away from the breast, using single port endoscopy, with Implant base reconstruction in pre pectoral position.
Complete excision of the gland by means of an incision on the axillary line, Installation of a definitive smooth prosthesis, Absence of conversion to a conventional approach, No skin necrosis
Measured: one day
Secondary outcomes (17)
Operative time
Duration of the prophylactic mastectomy with immediate breast reconstruction
Measured: one day
Open surgery conversion rate
Open surgery conversion rate
Measured: one day
Number of participants with an infection
Number of participants with early postoperative infection two months after the prophylactic mastectomy
Measured: 1 and 3 months after the prophylactic mastectomy
Blood loss
Blood loss (milliliters) during the prophylactic mastectomy with immediate breast reconstruction
Measured: one day
Number of participants with a local haematoma
Number of participants with a local haematoma caused by the prophylactic mastectomy with immediate breast reconstruction
Measured: Between the day of the prophylactic mastectomy and a month later
Disunity of the scar
Number of patients with disunity of the scar after the prophylactic mastectomy
Measured: 1, 3, 6 and 12 months after the prophylactic mastectomy
Exposure of the prosthesis
Number of patients with the prothesis exposed after the prophylactic mastectomy
Measured: 1, 3, 6 and 12 months after the prophylactic mastectomy
Post-operative seromas after the prophylactic mastectomy
Number of patients with seromas after the prophylactic mastectomy
Measured: 1, 3, 6 and 12 months after the prophylactic mastectomy
Complication rate of subcutaneous insufflation
Refractory induced hypercapnia: EtCO2 (expired fraction of CO2)> 45mmHg and refractory to ventilation ; second degree secondary burn
Measured: 3 and 12 months after the prophylactic mastectomy
Skin case necrosis
The presence of skin case necrosis will be noted during all the visits after the surgery. It's severe if > 25%
Measured: 1, 3, 6 and 12 months after the prophylactic mastectomy
Necrosis of areolo-nipple plaque
The presence of necrosis of areolo-nipple plaque will be noted during all the visits after the surgery.
Measured: 1, 3, 6 and 12 months after the prophylactic mastectomy
Analogue visual scale (EVA)
The level of pain of the operated breasts will be self-assessed by the patient with EVA at 1, 3, 6, 12 months after the surgery. EVA is mesured between 0 and 10 (0: no pain ; 10: extremely intense pain)
Measured: 1, 3, 6 and 12 months after the prophylactic mastectomy
Hospital stay
The duration of hospitalization will be noted upon discharge from hospitalization
Measured: Through discharge from hospitalization, an average of 7 days
Aesthetic result
BREAST-Q© questionnaire Version 2.0 measure the quality of life and satisfaction among patients undergoing breast surgery. This questionnaire includes 6 modules: 1) Augmentation module, 2) Reduction/Mastectomy module, 3) Breast cancer: a) Mastectomy module, b) Reconstruction module, c) Breast reconstruction expectations module, d) Breast conserving therapy module.
The conceptual framework of the modules is comprised of following two overarching themes (or domains): 1) Health-related quality of life and 2) Patient satisfaction. 1) Under each of these domains, there are six subthemes; Quality of life: 1) Psychosocial, 2) Physical and 3) Sexual well-being; and Patient satisfaction: 4) Satisfaction with Breasts, 5) Satisfaction with Outcome and 6) Satisfaction with care.
Cf. https://qportfolio.org/wp-content/uploads/2020/BREAST-Q-USERS-GUIDE-V2.pdf for the response options.
Measured: 3 and 12 months after the prophylactic mastectomy
Need for cosmetic reoperation
the need to use one or more lipomodelages
Measured: 3 and 12 months after the prophylactic mastectomy
Shoulder function
Evaluation of the Constant score by a physiotherapist from the gynecology Department. The Constant score includes 5 items: Pain [0;5], Daily activity level [0;10], Level of work with the hand [0;10], Mobility [0;40] and Muscular force [0;25].
The Constant score is mesured between 0 and 100. The higher the score, the fewer problems there are for the patient, 100 is the ideal score.
Measured: 3 months after the prophylactic mastectomy
Life quality
Quality of life with an european quality of life scale (EQ-5D-3L). The EQ-5D-3L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).
Measured: 3 and 12 months after the prophylactic mastectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start26 Apr 2019
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Genetic PredispositionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Association la Montpellier Reine a du Cœur
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838549
- Sponsor's protocol ID
- RECHMPL18_0244
- Other IDs
- UF 7672
- Acronym
- MRIMOP
- Status last verified
- Dec 2025
- First submitted
- 8 Feb 2019
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jakub JW, Peled AW, Gray RJ, Greenup RA, Kiluk JV, Sacchini V, McLaughlin SA, Tchou JC, Vierkant RA, Degnim AC, Willey S. Oncologic Safety of Prophylactic Nipple-Sparing Mastectomy in a Population With BRCA Mutations: A Multi-institutional Study. JAMA Surg. 2018 Feb 1;153(2):123-129. doi: 10.1001/jamasurg.2017.3422.
PubMed 28903167Colwell AS, Christensen JM. Nipple-Sparing Mastectomy and Direct-to-Implant Breast Reconstruction. Plast Reconstr Surg. 2017 Nov;140(5S Advances in Breast Reconstruction):44S-50S. doi: 10.1097/PRS.0000000000003949.
PubMed 29064921Muller T, Baratte A, Bruant-Rodier C, Bodin F, Mathelin C. Oncological safety of nipple-sparing prophylactic mastectomy: A review of the literature on 3716 cases. Ann Chir Plast Esthet. 2018 Jun;63(3):e6-e13. doi: 10.1016/j.anplas.2017.09.005. Epub 2017 Oct 10.
PubMed 29030030Casella D, Di Taranto G, Marcasciano M, Sordi S, Kothari A, Kovacs T, Lo Torto F, Cigna E, Ribuffo D, Calabrese C. Nipple-sparing bilateral prophylactic mastectomy and immediate reconstruction with TiLoop(R) Bra mesh in BRCA1/2 mutation carriers: A prospective study of long-term and patient reported outcomes using the BREAST-Q. Breast. 2018 Jun;39:8-13. doi: 10.1016/j.breast.2018.02.001. Epub 2018 Feb 18.
PubMed 29455110Miyake R, Kinoshita S, Shimada N, Uchida K, Takeyama H, Morikawa T. Preservation of the nipple-areola complex in skin-sparing mastectomy for early breast cancer. Surg Today. 2018 Jun;48(6):591-597. doi: 10.1007/s00595-018-1633-z. Epub 2018 Feb 21.
PubMed 29468434Co M, Chiu R, Chiu TM, Chong YC, Lau S, Lee YH, To HM, Kwong A. Nipple-Sparing Mastectomy and Its Application on BRCA Gene Mutation Carrier. Clin Breast Cancer. 2017 Dec;17(8):581-584. doi: 10.1016/j.clbc.2017.02.001. Epub 2017 Feb 14.
PubMed 28428099Ter Louw RP, Nahabedian MY. Prepectoral Breast Reconstruction. Plast Reconstr Surg. 2017 Nov;140(5S Advances in Breast Reconstruction):51S-59S. doi: 10.1097/PRS.0000000000003942.
PubMed 29064922Mitchell MP, Wagner J, Butterworth J. Subcutaneous implant-based breast reconstruction, a modern challenge in postmastectomy radiation planning. Pract Radiat Oncol. 2018 May-Jun;8(3):153-156. doi: 10.1016/j.prro.2017.09.001. Epub 2017 Sep 8.
PubMed 29233522Sbitany H, Piper M, Lentz R. Prepectoral Breast Reconstruction: A Safe Alternative to Submuscular Prosthetic Reconstruction following Nipple-Sparing Mastectomy. Plast Reconstr Surg. 2017 Sep;140(3):432-443. doi: 10.1097/PRS.0000000000003627.
PubMed 28574950Highton L, Johnson R, Kirwan C, Murphy J. Prepectoral Implant-Based Breast Reconstruction. Plast Reconstr Surg Glob Open. 2017 Sep 19;5(9):e1488. doi: 10.1097/GOX.0000000000001488. eCollection 2017 Sep.
PubMed 29062655Heidemann LN, Gunnarsson GL, Salzberg CA, Sorensen JA, Thomsen JB. Complications following Nipple-Sparing Mastectomy and Immediate Acellular Dermal Matrix Implant-based Breast Reconstruction-A Systematic Review and Meta-analysis. Plast Reconstr Surg Glob Open. 2018 Jan 12;6(1):e1625. doi: 10.1097/GOX.0000000000001625. eCollection 2018 Jan.
PubMed 29464161Glasberg SB. The Economics of Prepectoral Breast Reconstruction. Plast Reconstr Surg. 2017 Dec;140(6S Prepectoral Breast Reconstruction):49S-52S. doi: 10.1097/PRS.0000000000004051.
PubMed 29166348Kompatscher P. Endoscopic capsulotomy of capsular contracture after breast augmentation: a very challenging therapeutic approach. Plast Reconstr Surg. 1992 Dec;90(6):1125-6. doi: 10.1097/00006534-199212000-00049. No abstract available.
PubMed 1448521Lai HW, Chen ST, Chen DR, Chen SL, Chang TW, Kuo SJ, Kuo YL, Hung CS. Current Trends in and Indications for Endoscopy-Assisted Breast Surgery for Breast Cancer: Results from a Six-Year Study Conducted by the Taiwan Endoscopic Breast Surgery Cooperative Group. PLoS One. 2016 Mar 7;11(3):e0150310. doi: 10.1371/journal.pone.0150310. eCollection 2016.
PubMed 26950469Lai HW, Lin HY, Chen SL, Chen ST, Chen DR, Kuo SJ. Endoscopy-assisted surgery for the management of benign breast tumors: technique, learning curve, and patient-reported outcome from preliminary 323 procedures. World J Surg Oncol. 2017 Jan 11;15(1):19. doi: 10.1186/s12957-016-1080-5.
PubMed 28077134
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication
- ClinicalTrials.gov ID
- NCT03838549
- Acronym / sponsor ID
- MRIMOP / RECHMPL18_0244
- Conditions
- Genetic Predisposition, Breast Cancer
- Keywords
- Prophylactic Surgical Procedure, Subcutaneous Mastectomy, Endoscopy, Breast Reconstruction, Breast Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Association la Montpellier Reine a du Cœur
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 12 Feb 2019 (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.
Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume. Current techniques involve partial or total coverage of the implant with the pectoralis major muscle, to prevent exposure or infection. The muscle dissection technique applied has functional and cosmetic consequences. In this study, an endoscopic approach will be evaluated. This new surgical technique, using a single-port endoscopic way, will put the scar is in the axillary area, away from the breast. The hypothesis is that this delocalized scar potentially reduces the risk of exposure and allows placement of the implant in the subcutaneous space, with no manipulation of the pectoralis major muscle.
Detailed description
It s a practicability study, evaluating endoscopic approach for prophylactic mastectomy, using an axillary single port. Classic open surgery conversion rate, operative time, infectious rate, esthetical outcomes, and functional outcomes will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| implant for breast reconstruction | Experimental | Procedure: Prophylactic mastectomy with immediate breast reconstruction20 patients female with genetic risk for breast cancer and who ask for prophylactic mastectomy. They will have a prophylactic mastectomy with immediate breast reconstruction |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with an indication for prophylactic uni or bilateral mastectomy (Genetic risk factors for breast cancer)
- Ask an immediate breast reconstruction during the surgery
- World Heath Organization score <3
- Glandular volume : french bra cup size A, B ou C
- Glandular ptosis <=2 (Classification and Algorithm for Treatment of Breast Ptosis)
Key exclusion criteria (15 listed)
- History of breast cancer surgery
- Breast cancer not operated on the side concerned by the prophylactic mastectomy
- Patient having had irradiant treatment
- Breast hypertrophy
- Smoking > 10 cigarette/day
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 |
|---|---|---|
| Prophylactic mastectomy with immediate breast reconstructionIt is an endoscopic approach for prophylactic mastectomy using an axillary single port | Procedure or surgery | implant for breast reconstruction |
Primary outcome
success rate of total mastectomy
Time frame: one day
The total mastectomy is done by a scar in the axillary area, away from the breast, using single port endoscopy, with Implant base reconstruction in pre pectoral position. Complete excision of the gland by means of an incision on the axillary line, Installation of a definitive smooth prosthesis, Absence of conversion to a conventional approach, No skin necrosis
17 secondary outcomes
Operative time
Time frame: one day
Open surgery conversion rate
Time frame: one day
Number of participants with an infection
Time frame: 1 and 3 months after the prophylactic mastectomy
Blood loss
Time frame: one day
Number of participants with a local haematoma
Time frame: Between the day of the prophylactic mastectomy and a month later
Disunity of the scar
Time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
Exposure of the prosthesis
Time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
Post-operative seromas after the prophylactic mastectomy
Time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
Complication rate of subcutaneous insufflation
Time frame: 3 and 12 months after the prophylactic mastectomy
Skin case necrosis
Time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
Necrosis of areolo-nipple plaque
Time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
Analogue visual scale (EVA)
Time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
Hospital stay
Time frame: Through discharge from hospitalization, an average of 7 days
Aesthetic result
Time frame: 3 and 12 months after the prophylactic mastectomy
Need for cosmetic reoperation
Time frame: 3 and 12 months after the prophylactic mastectomy
Shoulder function
Time frame: 3 months after the prophylactic mastectomy
Life quality
Time frame: 3 and 12 months after the prophylactic mastectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 28903167Jakub JW, Peled AW, Gray RJ, Greenup RA, Kiluk JV, Sacchini V, McLaughlin SA, Tchou JC, Vierkant RA, Degnim AC, Willey S. Oncologic Safety of Prophylactic Nipple-Sparing Mastectomy in a Population With BRCA Mutations: A Multi-institutional Study. JAMA Surg. 2018 Feb 1;153(2):123-129. doi: 10.1001/jamasurg.2017.3422.
- Background: PubMed 29064921Colwell AS, Christensen JM. Nipple-Sparing Mastectomy and Direct-to-Implant Breast Reconstruction. Plast Reconstr Surg. 2017 Nov;140(5S Advances in Breast Reconstruction):44S-50S. doi: 10.1097/PRS.0000000000003949.
- Background: PubMed 29030030Muller T, Baratte A, Bruant-Rodier C, Bodin F, Mathelin C. Oncological safety of nipple-sparing prophylactic mastectomy: A review of the literature on 3716 cases. Ann Chir Plast Esthet. 2018 Jun;63(3):e6-e13. doi: 10.1016/j.anplas.2017.09.005. Epub 2017 Oct 10.
- Background: PubMed 29455110Casella D, Di Taranto G, Marcasciano M, Sordi S, Kothari A, Kovacs T, Lo Torto F, Cigna E, Ribuffo D, Calabrese C. Nipple-sparing bilateral prophylactic mastectomy and immediate reconstruction with TiLoop(R) Bra mesh in BRCA1/2 mutation carriers: A prospective study of long-term and patient reported outcomes using the BREAST-Q. Breast. 2018 Jun;39:8-13. doi: 10.1016/j.breast.2018.02.001. Epub 2018 Feb 18.
- Background: PubMed 29468434Miyake R, Kinoshita S, Shimada N, Uchida K, Takeyama H, Morikawa T. Preservation of the nipple-areola complex in skin-sparing mastectomy for early breast cancer. Surg Today. 2018 Jun;48(6):591-597. doi: 10.1007/s00595-018-1633-z. Epub 2018 Feb 21.
- Background: PubMed 28428099Co M, Chiu R, Chiu TM, Chong YC, Lau S, Lee YH, To HM, Kwong A. Nipple-Sparing Mastectomy and Its Application on BRCA Gene Mutation Carrier. Clin Breast Cancer. 2017 Dec;17(8):581-584. doi: 10.1016/j.clbc.2017.02.001. Epub 2017 Feb 14.
- Background: PubMed 29064922Ter Louw RP, Nahabedian MY. Prepectoral Breast Reconstruction. Plast Reconstr Surg. 2017 Nov;140(5S Advances in Breast Reconstruction):51S-59S. doi: 10.1097/PRS.0000000000003942.
- Background: PubMed 29233522Mitchell MP, Wagner J, Butterworth J. Subcutaneous implant-based breast reconstruction, a modern challenge in postmastectomy radiation planning. Pract Radiat Oncol. 2018 May-Jun;8(3):153-156. doi: 10.1016/j.prro.2017.09.001. Epub 2017 Sep 8.
- Background: PubMed 28574950Sbitany H, Piper M, Lentz R. Prepectoral Breast Reconstruction: A Safe Alternative to Submuscular Prosthetic Reconstruction following Nipple-Sparing Mastectomy. Plast Reconstr Surg. 2017 Sep;140(3):432-443. doi: 10.1097/PRS.0000000000003627.
- Background: PubMed 29062655Highton L, Johnson R, Kirwan C, Murphy J. Prepectoral Implant-Based Breast Reconstruction. Plast Reconstr Surg Glob Open. 2017 Sep 19;5(9):e1488. doi: 10.1097/GOX.0000000000001488. eCollection 2017 Sep.
- Background: PubMed 29464161Heidemann LN, Gunnarsson GL, Salzberg CA, Sorensen JA, Thomsen JB. Complications following Nipple-Sparing Mastectomy and Immediate Acellular Dermal Matrix Implant-based Breast Reconstruction-A Systematic Review and Meta-analysis. Plast Reconstr Surg Glob Open. 2018 Jan 12;6(1):e1625. doi: 10.1097/GOX.0000000000001625. eCollection 2018 Jan.
- Background: PubMed 29166348Glasberg SB. The Economics of Prepectoral Breast Reconstruction. Plast Reconstr Surg. 2017 Dec;140(6S Prepectoral Breast Reconstruction):49S-52S. doi: 10.1097/PRS.0000000000004051.
- Institut national du cancerLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic mastectomy with immediate breast reconstruction in people with Genetic Predisposition and Breast Cancer, run by University Hospital, Montpellier 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 8 inclusion and 15 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: finished, as of the sponsor's last update on 24 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
success rate of total mastectomy (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03838549, which also lists 27 linked publications.
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 Apr 2026.