Breast CancerNCT07372339
Comparison of Breast Sensory Recovery Between Conventional and Endoscopic Nipple-Sparing Mastectomy Combined With Prepectoral Implant Reconstruction
A study testing Conventional nipple-sparing mastectomy combined with prepectoral implant reconstruction and Endoscopic nipple-sparing mastectomy combined with prepectoral implant reconstruction in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
This clinical trial aims to determine whether conventional surgery or endoscopic surgery results in better recovery of breast skin sensation in women with early-stage breast cancer undergoing nipple-sparing mastectomy with prepectoral implant reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Conventional nipple-sparing mastectomy combined with prepectoral implant reconstruction and Endoscopic nipple-sparing mastectomy combined with prepectoral implant reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Mar 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 to 70 years.
- Unilateral breast cancer confirmed by preoperative pathology.
- Scheduled to undergo nipple-sparing mastectomy (NSM) with immediate prepectoral implant-based breast reconstruction.
- Invasive carcinoma with a maximum tumor diameter ≤ 5 cm, or ductal carcinoma in situ (DCIS).
- Preoperative imaging assessment confirms a distance of ≥ 1 cm between the lesion and the nipple-areola complex (NAC).
- No clinical, radiological, or pathological evidence of tumor invasion into the NAC, skin, or pectoralis major muscle. The tumor must be confined within the glandular tissue.
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- No evidence of distant metastasis (M0).
- Clinically node-negative (cN0) as assessed by preoperative examination.
- No history of neoadjuvant chemotherapy or radiotherapy prior to surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Willing and able to understand the study procedures, provide written informed consent, demonstrate good compliance, and agree to participate in follow-up evaluations.
- The principal surgeon must have experience in performing at least 30 cases of NSM combined with implant-based reconstruction.
Who cannot join
- Diagnosis of Paget's disease of the breast, recurrent breast cancer, or a history of prior thoracic radiation therapy.
- Evidence of tumor invasion into the skin (including inflammatory breast cancer), nipple-areola complex, or pectoralis major muscle.
- Pregnancy or lactation at the time of enrollment.
- Requirement for re-excision following a prior breast lump biopsy, or a history of any previous breast surgery (including but not limited to augmentation mammoplasty, breast reduction, lumpectomy, etc.).
- Breast size exceeding a D-cup.
- Body mass index (BMI) > 30 kg/m².
Show all 15Show fewer
- Grade III ptosis (severe breast drooping where the nipple is positioned below the inframammary fold).
- Pre-existing nipple-areolar complex deformities (e.g., nipple inversion, areolar hypoplasia), active skin conditions of the breast (e.g., eczema, dermatitis, infection, ulceration), or significant scarring compromising the surgical site.
- Severe systemic comorbidities (e.g., immunosuppression, uncontrolled diabetes mellitus, severe cardiopulmonary dysfunction, coagulopathy or bleeding diathesis, contraindications to general anesthesia).
- Known hypersensitivity or allergy to silicone gel implants, or to anesthetic agents/antibiotics used perioperatively.
- Pre-existing neurological disorders (e.g., diabetic peripheral neuropathy, Parkinson's disease, polyneuritis, spinal cord injury) or chronic use of medications known to affect neurological/sensory function (e.g., antidepressants, antiepileptics).
- Current heavy smoking (>20 cigarettes per day).
- Current alcohol abuse or substance addiction.
- Concurrent or history of other active malignancies
- Anticipated poor compliance with follow-up protocols or inability to complete scheduled postoperative evaluations.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Breast Sensory Recovery Between Conventional and Endoscopic Nipple-Sparing Mastectomy Combined With Prepectoral Implant Reconstruction：an Open-label, Multicentre, Randomised, Controlled Trial
This clinical trial aims to determine whether conventional surgery or endoscopic surgery results in better recovery of breast skin sensation in women with early-stage breast cancer undergoing nipple-sparing mastectomy with prepectoral implant reconstruction. Furthermore, the study will compare the safety, aesthetic outcomes, and quality of life associated with the two surgical approaches. The study seeks to address the following primary research questions:
Does conventional surgery lead to superior recovery of breast skin sensation at 6 months postoperatively compared with endoscopic surgery?
Read more
What are the differences between the two surgical approaches in terms of complication rates, aesthetic outcomes, and patient-reported quality of life?
Researchers will compare conventional nipple-sparing mastectomy with endoscopic nipple-sparing mastectomy to determine which procedure better preserves postoperative breast sensation.
Participants will:
Be randomly assigned to undergo either conventional or endoscopic surgery.
Have breast skin sensation measured preoperatively and at multiple postoperative follow-up visits using a standardized assessment tool.
Complete validated questionnaires regarding breast satisfaction and quality of life preoperatively and during multiple follow-up visits.
Attend scheduled follow-up visits to monitor for complications and to evaluate the long-term appearance and health of the reconstructed breast.
- Conditions
- Breast Cancer
- Being tested
- Conventional nipple-sparing mastectomy combined with prepectoral implant reconstruction, Endoscopic nipple-sparing mastectomy combined with prepectoral implant reconstruction
- Keywords
- Breast Reconstruction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional nipple-sparing mastectomy combined with prepectoral implant reconstructionProcedure or surgery
This procedure is a traditional surgical approach involving a skin incision made on the breast surface. Under direct visualization, the breast glandular tissue is excised while preserving the nipple-areola complex, followed by a reconstructive surgery with implant placement in the prepectoral plane.
Endoscopic nipple-sparing mastectomy combined with prepectoral implant reconstructionProcedure or surgery
This minimally invasive procedure is performed through small, concealed incisions in the axilla. Utilizing endoscopic instruments and an imaging system, the breast glandular tissue is resected under video monitoring, followed by reconstructive surgery with implant placement in the prepectoral plane.
| Study group | Role | What they receive |
|---|---|---|
| Conventional nipple-sparing mastectomy group | Experimental | Not described Receives: Procedure: Conventional nipple-sparing mastectomy combined with prepectoral implant reconstruction |
| Endoscopic nipple-sparing mastectomy group | Active comparator | Not described Receives: Procedure: Endoscopic nipple-sparing mastectomy combined with prepectoral implant reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average breast sensory thresholds at 6 months post breast reconstruction as measured by Semmes-Weinstein Monofilaments
Differences in the mean skin sensory thresholds (measured by Semmes-Weinstein monofilaments across nine breast regions) between the conventional and endoscopic surgery groups were observed at 6 months after breast reconstruction.
Measured: 6 months
Secondary outcomes (9)
Number of participants with postoperative complications as assessed by Clavien-Dindo Classification System within 1 year after surgery
Complications (e.g., hematoma, infection, flap necrosis) will be recorded and graded according to the Clavien-Dindo Classification System. The outcome is the count (and percentage) of participants experiencing at least one complication within the first postoperative year. These events are assessed at scheduled follow-up visits at 1, 3, 6, and 12 months.
Measured: within 1 year
Patient-reported quality of life as measured by Breast-Q reconstruction module
The Breast-Q reconstruction module assesses multiple domains, including psychosocial well-being, sexual well-being, physical well-being (of the chest and upper body), and satisfaction with breasts. All scores are transformed to a 0-100 scale.
Measured: 6 months and 1 year
Physician-assessed breast aesthetic score using a 5-point Likert scale
Independent surgeons will rate five specific domains (volume, shape, symmetry, scar, NAC) on a 5-point Likert scale (1=very dissatisfied to 5=very satisfied) using blinded photographs. The mean score for each domain and the composite mean score will be compared between groups.
Measured: 6 months and 1 year
Patient-reported quality of life as assessed by E0RTC QLQ-C30
Patient-reported quality of life measured by E0RTC QLQ-C30, consists of 30 items grouped into functional scales, symptom scales and single items, global health status scale. Responses for most items are recorded on a 4-point Likert scale (1="Not at all" to 4="Very much"). The two Global Health Status items use a 7-point linear analogue scale (1="Very poor" to 7="Excellent"). Raw scores are linearly transformed to a standardized score ranging from 0 to 100 for each scale. For the functional scales and the global health status scale: a higher score indicates a better level of functioning or quality of life. For the symptom scales / single Items: a higher score indicates a greater severity of symptoms or problems.
Measured: 6 months and 1 year
Long-term breast skin sensation threshold as measured by Semmes-Weinstein Monofilaments
The mean pressure threshold, measured in grams using the Semmes-Weinstein monofilament test across nine standardized breast regions, will be compared between the conventional surgery group and the endoscopic surgery group after nipple-sparing mastectomy with prepectoral implant reconstruction for a long time.
Measured: Annually up to 10 years
Number of participants with postoperative complications as assessed by Clavien-Dindo Classification System after surgery in the long term.
Number of participants with postoperative complications assessed by Clavien-Dindo Classification System will be compared between two groups annually in the long term.
Measured: Annually up to 10 years
Long-term physician-assessed breast aesthetic score
Independent surgeons will rate five specific domains (volume, shape, symmetry, scar, NAC) on a 5-point Likert scale (1=very dissatisfied to 5=very satisfied) using blinded photographs. The mean score will be compared between groups at annual follow-ups.
Measured: Annually up to 10 years
Long-term patient-reported quality of life as measured by Breast-Q reconstruction module
The Breast-Q reconstruction module assesses multiple domains, including psychosocial well-being, sexual well-being, physical well-being (of the chest and upper body), and satisfaction with breasts. All scores are transformed to a 0-100 scale. The mean score will be compared between groups at annual follow-ups.
Measured: Annually up to 10 years
Long-term patient-reported quality of life as assessed by EORTC-QLQ-C30
Long-term patient-reported quality of life measured by E0RTC QLQ-C30, consists of 30 items grouped into functional scales, symptom scales and single items, global health status scale. Responses for most items are recorded on a 4-point Likert scale (1="Not at all" to 4="Very much"). The two Global Health Status items use a 7-point linear analogue scale (1="Very poor" to 7="Excellent"). Raw scores are linearly transformed to a standardized score ranging from 0 to 100 for each scale. For the functional scales and the global health status scale: a higher score indicates a better level of functioning or quality of life. For the symptom scales / single Items: a higher score indicates a greater severity of symptoms or problems.
Measured: Annually up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372339
- Sponsor's protocol ID
- NJMU-BC11
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim JH, Ryu JM, Bae SJ, Ko BS, Choi JE, Kim KS, Cha C, Choi YJ, Lee HY, Nam SE, Kim Z, Kang YJ, Lee MH, Lee JE, Park E, Shin HJ, Kim MK, Choi HJ, Kwon SU, Son NH, Park HS, Lee J; Korea Robot-endoscopy Minimal Access Breast Surgery Study Group. Minimal Access vs Conventional Nipple-Sparing Mastectomy. JAMA Surg. 2024 Oct 1;159(10):1177-1186. doi: 10.1001/jamasurg.2024.2977.
PubMed 39141399Hammond JB, Kandi LA, Armstrong VL, Kosiorek HE, Rebecca AM, Casey WJ 3rd, Kruger EA, Cronin PA, Pockaj BA, Teven CM. Long-term breast and nipple sensation after nipple-sparing mastectomy with implant reconstruction: Relevance to physical, psychosocial, and sexual well-being. J Plast Reconstr Aesthet Surg. 2022 Sep;75(9):2914-2919. doi: 10.1016/j.bjps.2022.06.034. Epub 2022 Jun 20.
PubMed 35915018Lai HW, Chang YL, Chandrachamnong K, See MH, Huang HI, Lin SL, Fang DY, Chen ST, Chen DR, Mok CW, Cheng FT. Factors associated with alteration of nipple or skin sensation and impact of duration of time following nipple-sparing mastectomy (NSM): an analysis of 460 cases with comparison of conventional versus endoscopic- or robotic-assisted NSM. World J Surg Oncol. 2023 Jul 26;21(1):222. doi: 10.1186/s12957-023-03107-5.
PubMed 37491239Zhou J, Xie Y, Liang F, Feng Y, Yang H, Qiu M, Zhang Q, Chung K, Dai H, Liu Y, Liang P, Du Z. A novel technique of reverse-sequence endoscopic nipple-sparing mastectomy with direct-to-implant breast reconstruction: medium-term oncological safety outcomes and feasibility of 24-h discharge for breast cancer patients. Int J Surg. 2024 Apr 1;110(4):2243-2252. doi: 10.1097/JS9.0000000000001134.
PubMed 38348883Seth AK, Sisco M. Prepectoral Breast Reconstruction. Plast Reconstr Surg. 2025 Jan 1;155(1):213e-227e. doi: 10.1097/PRS.0000000000011737. Epub 2024 Dec 16.
PubMed 39700251
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Breast Sensory Recovery Between Conventional and Endoscopic Nipple-Sparing Mastectomy Combined With Prepectoral Implant Reconstruction：an Open-label, Multicentre, Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT07372339
- Acronym / sponsor ID
- NJMU-BC11
- Conditions
- Breast Cancer
- Keywords
- Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2036 (estimated)
- First posted
- 28 Jan 2026 (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.
This clinical trial aims to determine whether conventional surgery or endoscopic surgery results in better recovery of breast skin sensation in women with early-stage breast cancer undergoing nipple-sparing mastectomy with prepectoral implant reconstruction. Furthermore, the study will compare the safety, aesthetic outcomes, and quality of life associated with the two surgical approaches. The study seeks to address the following primary research questions:
Does conventional surgery lead to superior recovery of breast skin sensation at 6 months postoperatively compared with endoscopic surgery?
What are the differences between the two surgical approaches in terms of complication rates, aesthetic outcomes, and patient-reported quality of life?
Researchers will compare conventional nipple-sparing mastectomy with endoscopic nipple-sparing mastectomy to determine which procedure better preserves postoperative breast sensation.
Participants will:
Be randomly assigned to undergo either conventional or endoscopic surgery.
Have breast skin sensation measured preoperatively and at multiple postoperative follow-up visits using a standardized assessment tool.
Complete validated questionnaires regarding breast satisfaction and quality of life preoperatively and during multiple follow-up visits.
Attend scheduled follow-up visits to monitor for complications and to evaluate the long-term appearance and health of the reconstructed breast.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional nipple-sparing mastectomy group | Experimental | Procedure: Conventional nipple-sparing mastectomy combined with prepectoral implant reconstruction |
| Endoscopic nipple-sparing mastectomy group | Active comparator | Procedure: Endoscopic nipple-sparing mastectomy combined with prepectoral implant reconstruction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female patients aged 18 to 70 years.
- Unilateral breast cancer confirmed by preoperative pathology.
- Scheduled to undergo nipple-sparing mastectomy (NSM) with immediate prepectoral implant-based breast reconstruction.
- Invasive carcinoma with a maximum tumor diameter ≤ 5 cm, or ductal carcinoma in situ (DCIS).
- Preoperative imaging assessment confirms a distance of ≥ 1 cm between the lesion and the nipple-areola complex (NAC).
Key exclusion criteria (15 listed)
- Diagnosis of Paget's disease of the breast, recurrent breast cancer, or a history of prior thoracic radiation therapy.
- Evidence of tumor invasion into the skin (including inflammatory breast cancer), nipple-areola complex, or pectoralis major muscle.
- Pregnancy or lactation at the time of enrollment.
- Requirement for re-excision following a prior breast lump biopsy, or a history of any previous breast surgery (including but not limited to augmentation mammoplasty, breast reduction, lumpectomy, etc.).
- Breast size exceeding a D-cup.
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 |
|---|---|---|
| Conventional nipple-sparing mastectomy combined with prepectoral implant reconstructionThis procedure is a traditional surgical approach involving a skin incision made on the breast surface. Under direct visualization, the breast glandular tissue is excised while preserving the nipple-areola complex, followed by a reconstructive surgery with implant placement in the prepectoral plane. | Procedure or surgery | Conventional nipple-sparing mastectomy group |
| Endoscopic nipple-sparing mastectomy combined with prepectoral implant reconstructionThis minimally invasive procedure is performed through small, concealed incisions in the axilla. Utilizing endoscopic instruments and an imaging system, the breast glandular tissue is resected under video monitoring, followed by reconstructive surgery with implant placement in the prepectoral plane. | Procedure or surgery | Endoscopic nipple-sparing mastectomy group |
Primary outcome
Average breast sensory thresholds at 6 months post breast reconstruction as measured by Semmes-Weinstein Monofilaments
Time frame: 6 months
Differences in the mean skin sensory thresholds (measured by Semmes-Weinstein monofilaments across nine breast regions) between the conventional and endoscopic surgery groups were observed at 6 months after breast reconstruction.
9 secondary outcomes
Number of participants with postoperative complications as assessed by Clavien-Dindo Classification System within 1 year after surgery
Time frame: within 1 year
Patient-reported quality of life as measured by Breast-Q reconstruction module
Time frame: 6 months and 1 year
Physician-assessed breast aesthetic score using a 5-point Likert scale
Time frame: 6 months and 1 year
Patient-reported quality of life as assessed by E0RTC QLQ-C30
Time frame: 6 months and 1 year
Long-term breast skin sensation threshold as measured by Semmes-Weinstein Monofilaments
Time frame: Annually up to 10 years
Number of participants with postoperative complications as assessed by Clavien-Dindo Classification System after surgery in the long term.
Time frame: Annually up to 10 years
Long-term physician-assessed breast aesthetic score
Time frame: Annually up to 10 years
Long-term patient-reported quality of life as measured by Breast-Q reconstruction module
Time frame: Annually up to 10 years
Long-term patient-reported quality of life as assessed by EORTC-QLQ-C30
Time frame: Annually up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background: PubMed 39141399Kim JH, Ryu JM, Bae SJ, Ko BS, Choi JE, Kim KS, Cha C, Choi YJ, Lee HY, Nam SE, Kim Z, Kang YJ, Lee MH, Lee JE, Park E, Shin HJ, Kim MK, Choi HJ, Kwon SU, Son NH, Park HS, Lee J; Korea Robot-endoscopy Minimal Access Breast Surgery Study Group. Minimal Access vs Conventional Nipple-Sparing Mastectomy. JAMA Surg. 2024 Oct 1;159(10):1177-1186. doi: 10.1001/jamasurg.2024.2977.
- Background: PubMed 35915018Hammond JB, Kandi LA, Armstrong VL, Kosiorek HE, Rebecca AM, Casey WJ 3rd, Kruger EA, Cronin PA, Pockaj BA, Teven CM. Long-term breast and nipple sensation after nipple-sparing mastectomy with implant reconstruction: Relevance to physical, psychosocial, and sexual well-being. J Plast Reconstr Aesthet Surg. 2022 Sep;75(9):2914-2919. doi: 10.1016/j.bjps.2022.06.034. Epub 2022 Jun 20.
- Background: PubMed 37491239Lai HW, Chang YL, Chandrachamnong K, See MH, Huang HI, Lin SL, Fang DY, Chen ST, Chen DR, Mok CW, Cheng FT. Factors associated with alteration of nipple or skin sensation and impact of duration of time following nipple-sparing mastectomy (NSM): an analysis of 460 cases with comparison of conventional versus endoscopic- or robotic-assisted NSM. World J Surg Oncol. 2023 Jul 26;21(1):222. doi: 10.1186/s12957-023-03107-5.
- Background: PubMed 38348883Zhou J, Xie Y, Liang F, Feng Y, Yang H, Qiu M, Zhang Q, Chung K, Dai H, Liu Y, Liang P, Du Z. A novel technique of reverse-sequence endoscopic nipple-sparing mastectomy with direct-to-implant breast reconstruction: medium-term oncological safety outcomes and feasibility of 24-h discharge for breast cancer patients. Int J Surg. 2024 Apr 1;110(4):2243-2252. doi: 10.1097/JS9.0000000000001134.
- Background: PubMed 39700251Seth AK, Sisco M. Prepectoral Breast Reconstruction. Plast Reconstr Surg. 2025 Jan 1;155(1):213e-227e. doi: 10.1097/PRS.0000000000011737. Epub 2024 Dec 16.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional nipple-sparing mastectomy combined with prepectoral implant reconstruction and Endoscopic nipple-sparing mastectomy combined with prepectoral implant reconstruction in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
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 12 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: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen Bin Zhou, professor (13814162016, zhouwenbin@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average breast sensory thresholds at 6 months post breast reconstruction as measured by Semmes-Weinstein Monofilaments (time frame: 6 months). 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 NCT07372339, which also lists 5 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 28 Jan 2026.