Breast Reconstruction After MastectomyNCT07308275
Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components
A study testing Autologous Breast Reconstruction With Direct Neurotization and Autologous Breast Reconstruction without Neurotization in people with Breast Reconstruction After Mastectomy and Neurotization, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
Trial summary
This clinical trial aims to evaluate whether direct neurotization using fully autologous components during autologous breast reconstruction improves postoperative breast sensation and sensory-related quality of life in women undergoing unilateral mastectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction After Mastectomy, Neurotization, Mastectomy and Breast Reconstruction
- What is being tested?
- Autologous Breast Reconstruction With Direct Neurotization and Autologous Breast Reconstruction without Neurotization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Dec 2025to 15 Apr 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥18 years.
- Patients with unilateral breast cancer who have undergone or will undergo unilateral mastectomy.
- Patients undergoing breast reconstruction.
- Patients with unilateral breast cancer regardless of adjuvant therapy status (receiving radiotherapy and/or chemotherapy or receiving no adjuvant therapy).
- Willing to comply with all scheduled examinations and tissue sampling procedures.
- Able and willing to provide written informed consent.
Who cannot join
- History of peripheral neuropathy (e.g., diabetes mellitus with neuropathic complications).
- Bilateral mastectomy.
- Presence of skin or soft-tissue conditions of the breast that may interfere with sensory assessment.
- Active smokers (use of tobacco, vape, or other nicotine products within 14 days prior to neurotization).
- Refusal or inability to attend follow-up evaluations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
dr. Ciptomangunkusumo National Hospital - Faculty of Medicine Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
Ayu PB Sarena, MD, MPH, +6285121316121, ayusarena16@gmail.com
Mohamad Rachadian Ramadan, MD, MRBS
About this study
Official title: Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components: An Assessment of BREAST-Q Sensation Module, Cutaneous Pressure Threshold, Neuregulin 1 (NRG1) Expression, Nerve Fiber Cross-sectional Area, Intraepidermal Nerve Fiber Density (IENFD), and Breast Morphometry
This clinical trial aims to evaluate whether direct neurotization using fully autologous components during autologous breast reconstruction improves postoperative breast sensation and sensory-related quality of life in women undergoing unilateral mastectomy. Direct neurotization involves coapting the recipient intercostal nerve to an autologous nerve graft placed within the flap to facilitate reinnervation.
The study's primary questions are:
Read more
- Does direct neurotization using fully autologous nerve grafts improve cutaneous sensory recovery, as assessed by Semmes-Weinstein monofilament thresholds measured at standardized breast locations?
- Does neurotization enhance patient-reported sensory outcomes and quality of life, as assessed by the BREAST-Q Sensation Module?
As secondary objectives, the study will assess whether biological predictors of nerve regeneration correlate with sensory outcomes. These include:
- Neuregulin-1 (NRG1) expression in flap tissue biopsy;
- Cross-sectional area of the recipient nerve fibres;
- Breast morphometry measured at baseline and follow-up;
- Intraepidermal nerve fibre density (IENFD) on skin biopsy.
Participants will be randomly assigned to receive either:
- Neurotized autologous breast reconstruction using fully autologous graft components, or
- Standard (non-neurotized) autologous breast reconstruction.
The study will compare these groups to determine whether neurotization accelerates or enhances the return of breast sensation over a 6-month follow-up period, with evaluations at 1 month, 3 months, and 6 months after surgery.
Participants will undergo:
- Autologous breast reconstruction with or without direct neurotization as part of their planned cancer surgery.
- Sensory testing using Semmes-Weinstein monofilaments at baseline, 1, 3, and 6 months.
- Completion of BREAST-Q questionnaires evaluating breast sensation, symptoms, and quality of life at each follow-up visit.
- Intraoperative tissue sampling for NRG1 analysis and nerve morphometry. 4. Skin biopsy (if applicable) to assess intraepidermal nerve fibre density. 5. Breast morphometry assessment using a breast morphometry measurement software tool.
This study seeks to provide high-quality evidence on the effectiveness of direct neurotization using fully autologous components in restoring breast sensation and to explore biological predictors that may influence sensory recovery after autologous breast reconstruction.
- Conditions
- Breast Reconstruction After Mastectomy, Neurotization, Mastectomy and Breast Reconstruction, Peripheral Nerve Regeneration, Sensory Function, Quality of Life (QOL)
- Being tested
- Autologous Breast Reconstruction With Direct Neurotization, Autologous Breast Reconstruction without Neurotization
- Keywords
- breast neurotization, mastectomy, breast sensory, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Breast Reconstruction With Direct NeurotizationProcedure or surgery
The direct neurotization using fully autologous components procedures include:
- Direct neurotization is carried out using fully autologous components, involving coaptation of the recipient nerve to an autologous nerve graft placed within the flap to facilitate reinnervation.
- Surgical breast reconstruction is then completed using patient's own tissue
Autologous Breast Reconstruction without NeurotizationProcedure or surgery
Breast reconstruction is performed using autologous tissue without nerve coaptation or neurotization, according to standard surgical practice.
| Study group | Role | What they receive |
|---|---|---|
| Non-Neurotized Group | Active comparator | Participants assigned to this arm are women undergoing mastectomy who are eligible for standard autologous breast reconstruction without neurotization. Receives: Procedure: Autologous Breast Reconstruction without Neurotization |
| Neurotized Group | Experimental | Participants assigned to this arm are women undergoing mastectomy who are eligible for autologous breast reconstruction with planned direct neurotization using fully autologous components. Receives: Procedure: Autologous Breast Reconstruction With Direct Neurotization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Sensation assessed by using Semmes-Weinstein Monofilament testing
SWM thresholds at nine standardized points on the reconstructed breast will be measured using calibrated monofilaments, categorized into levels of normal touch, diminished light touch, diminished protective sensation, loss of protective sensation, and deep pressure only.
Measured: 1, 3 and 6 months after Neurotization
Patient's Quality of Life assessed by using BREAST-Q® Sensation Module
The patient reported outcomes will be recorded in BREAST-Q® Sensation Module to capture the sensation, breast symptoms, and quality of life impact of sensation loss.
Measured: 1, 3 and 6 months after Neurotization
Secondary outcomes (4)
Neuregulin 1 Expression
NRG1 expression quantified by ELISA from flap tissue
Measured: During procedure and 6 months after surgery
Nerve Cross-sectional Area
Nerve cross-sectional area measured via histomorphometry/histopathology using the recipient nerve of the direct neurotization method
Measured: Measured during neurotization procedure
Breast Morphometry
Breast morphometry assessed using a validated AR/3D application
Measured: Before surgery and 1, 3, 6 months after surgery
Intraepidermal Nerve Fibre Density (IENFD)
IENFD quantified by counting PGP9.5-positive intraepidermal fibers per mm of epidermal length. Flap skin tissue samples will be taken using 3 mm punch biopsy
Measured: During procedure and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Breast Reconstruction After MastectomyStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Rachadian Ramadan, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308275
- Sponsor's protocol ID
- STUDINEUROTISASI
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to concerns regarding participant confidentiality and the potential risk of re-identification in a small surgical trial with detailed clinical and biomarker data.
Publications
Bubberman JM, Brandts L, van Kuijk SMJ, van der Hulst RRWJ, Tuinder SMH. The efficacy of sensory nerve coaptation in DIEP flap breast reconstruction - Preliminary results of a double-blind randomized controlled trial. Breast. 2024 Apr;74:103691. doi: 10.1016/j.breast.2024.103691. Epub 2024 Feb 9.
PubMed 38401421Timar B, Popescu S, Timar R, Baderca F, Duica B, Vlad M, Levai C, Balinisteanu B, Simu M. The usefulness of quantifying intraepidermal nerve fibers density in the diagnostic of diabetic peripheral neuropathy: a cross-sectional study. Diabetol Metab Syndr. 2016 Apr 11;8:31. doi: 10.1186/s13098-016-0146-4. eCollection 2016.
PubMed 27069510Samolis A, Troupis T, Politis C, Pantazis N, Triantafyllou G, Tsakotos G, Tegos T, Lazaridis N, Natsis K, Piagkou M. Intraepidermal Nerve Fiber Density as an Indicator of Neuropathy Predisposition: A Systematic Review with Meta-Analysis. Diagnostics (Basel). 2025 May 23;15(11):1311. doi: 10.3390/diagnostics15111311.
PubMed 40506883La Padula S, Pensato R, D'Andrea F, de Gregorio L, Errico C, Rega U, Canta L, Pizza C, Roccaro G, Billon R, Dibra E, Meningaud JP, Hersant B. Assessment of Patient Satisfaction Using a New Augmented Reality Simulation Software for Breast Augmentation: A Prospective Study. J Clin Med. 2022 Jun 16;11(12):3464. doi: 10.3390/jcm11123464.
PubMed 35743534Song S, Parmeshwar N, Steiner G, Kim EA. Morphometric Analysis of Gender-affirming Breast Augmentation. Plast Reconstr Surg Glob Open. 2022 Nov 29;10(11):e4691. doi: 10.1097/GOX.0000000000004691. eCollection 2022 Nov.
PubMed 36467119Bin JM, Suminaite D, Benito-Kwiecinski SK, Kegel L, Rubio-Brotons M, Early JJ, Soong D, Livesey MR, Poole RJ, Lyons DA. Importin 13-dependent axon diameter growth regulates conduction speeds along myelinated CNS axons. Nat Commun. 2024 Feb 27;15(1):1790. doi: 10.1038/s41467-024-45908-6.
PubMed 38413580Clark IA, Mohammadi S, Callaghan MF, Maguire EA. Conduction velocity along a key white matter tract is associated with autobiographical memory recall ability. Elife. 2022 Sep 27;11:e79303. doi: 10.7554/eLife.79303.
PubMed 36166372Fricker FR, Lago N, Balarajah S, Tsantoulas C, Tanna S, Zhu N, Fageiry SK, Jenkins M, Garratt AN, Birchmeier C, Bennett DL. Axonally derived neuregulin-1 is required for remyelination and regeneration after nerve injury in adulthood. J Neurosci. 2011 Mar 2;31(9):3225-33. doi: 10.1523/JNEUROSCI.2568-10.2011.
PubMed 21368034Stassart RM, Fledrich R, Velanac V, Brinkmann BG, Schwab MH, Meijer D, Sereda MW, Nave KA. A role for Schwann cell-derived neuregulin-1 in remyelination. Nat Neurosci. 2013 Jan;16(1):48-54. doi: 10.1038/nn.3281. Epub 2012 Dec 9.
PubMed 23222914Dellon ES, Crone S, Mouery R, Dellon AL. Comparison of the Semmes-Weinstein monofilaments with the Pressure-Specifying Sensory Device. Restor Neurol Neurosci. 1993 Jan 1;5(5):323-6. doi: 10.3233/RNN-1993-55602.
PubMed 21551718Voineskos SH, Klassen AF, Cano SJ, Pusic AL, Gibbons CJ. Giving Meaning to Differences in BREAST-Q Scores: Minimal Important Difference for Breast Reconstruction Patients. Plast Reconstr Surg. 2020 Jan;145(1):11e-20e. doi: 10.1097/PRS.0000000000006317.
PubMed 31577663Gallo L, Chu JJ, Shamsunder MG, Hatchell A, Patel AR, Godwin K, Hernandez M, Pusic AL, Nelson JA, Voineskos SH. Best Practices for BREAST-Q Research: A Systematic Review of Study Methodology. Plast Reconstr Surg. 2022 Sep 1;150(3):526e-535e. doi: 10.1097/PRS.0000000000009401. Epub 2022 Jun 24.
PubMed 35749737Ramadan MR, Rifai DA, Atmodiwirjo P, Panigoro SS, Mukarramah DA, Sobri FB, Jurisman A, Djohan R. Indonesian Translation and Cultural Adaptation of the BREAST-Q Reconstruction Module. Plast Reconstr Surg Glob Open. 2025 Apr 21;13(4):e6705. doi: 10.1097/GOX.0000000000006705. eCollection 2025 Apr.
PubMed 40264905Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Shiah E, Laikhter E, Comer CD, Manstein SM, Bustos VP, Bain PA, Lee BT, Lin SJ. Neurotization in Innervated Breast Reconstruction: A Systematic Review of Techniques and Outcomes. J Plast Reconstr Aesthet Surg. 2022 Sep;75(9):2890-2913. doi: 10.1016/j.bjps.2022.06.006. Epub 2022 Jun 17.
PubMed 35872020
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components: An Assessment of BREAST-Q Sensation Module, Cutaneous Pressure Threshold, Neuregulin 1 (NRG1) Expression, Nerve Fiber Cross-sectional Area, Intraepidermal Nerve Fiber Density (IENFD), and Breast Morphometry
- ClinicalTrials.gov ID
- NCT07308275
- Acronym / sponsor ID
- STUDINEUROTISASI
- Conditions
- Breast Reconstruction After Mastectomy, Neurotization, Mastectomy and Breast Reconstruction, Peripheral Nerve Regeneration, Sensory Function, Quality of Life (QOL)
- Keywords
- breast neurotization, mastectomy, breast sensory, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 29 Dec 2025 (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 evaluate whether direct neurotization using fully autologous components during autologous breast reconstruction improves postoperative breast sensation and sensory-related quality of life in women undergoing unilateral mastectomy. Direct neurotization involves coapting the recipient intercostal nerve to an autologous nerve graft placed within the flap to facilitate reinnervation.
The study's primary questions are:
- Does direct neurotization using fully autologous nerve grafts improve cutaneous sensory recovery, as assessed by Semmes-Weinstein monofilament thresholds measured at standardized breast locations?
- Does neurotization enhance patient-reported sensory outcomes and quality of life, as assessed by the BREAST-Q Sensation Module?
As secondary objectives, the study will assess whether biological predictors of nerve regeneration correlate with sensory outcomes. These include:
- Neuregulin-1 (NRG1) expression in flap tissue biopsy;
- Cross-sectional area of the recipient nerve fibres;
- Breast morphometry measured at baseline and follow-up;
- Intraepidermal nerve fibre density (IENFD) on skin biopsy.
Participants will be randomly assigned to receive either:
- Neurotized autologous breast reconstruction using fully autologous graft components, or
- Standard (non-neurotized) autologous breast reconstruction.
The study will compare these groups to determine whether neurotization accelerates or enhances the return of breast sensation over a 6-month follow-up period, with evaluations at 1 month, 3 months, and 6 months after surgery.
Participants will undergo:
- Autologous breast reconstruction with or without direct neurotization as part of their planned cancer surgery.
- Sensory testing using Semmes-Weinstein monofilaments at baseline, 1, 3, and 6 months.
- Completion of BREAST-Q questionnaires evaluating breast sensation, symptoms, and quality of life at each follow-up visit.
- Intraoperative tissue sampling for NRG1 analysis and nerve morphometry. 4. Skin biopsy (if applicable) to assess intraepidermal nerve fibre density. 5. Breast morphometry assessment using a breast morphometry measurement software tool.
This study seeks to provide high-quality evidence on the effectiveness of direct neurotization using fully autologous components in restoring breast sensation and to explore biological predictors that may influence sensory recovery after autologous breast reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Neurotized Group | Active comparator | Procedure: Autologous Breast Reconstruction without NeurotizationParticipants assigned to this arm are women undergoing mastectomy who are eligible for standard autologous breast reconstruction without neurotization. |
| Neurotized Group | Experimental | Procedure: Autologous Breast Reconstruction With Direct NeurotizationParticipants assigned to this arm are women undergoing mastectomy who are eligible for autologous breast reconstruction with planned direct neurotization using fully autologous components. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients aged ≥18 years.
- Patients with unilateral breast cancer who have undergone or will undergo unilateral mastectomy.
- Patients undergoing breast reconstruction.
- Patients with unilateral breast cancer regardless of adjuvant therapy status (receiving radiotherapy and/or chemotherapy or receiving no adjuvant therapy).
- Willing to comply with all scheduled examinations and tissue sampling procedures.
Key exclusion criteria (5 listed)
- History of peripheral neuropathy (e.g., diabetes mellitus with neuropathic complications).
- Bilateral mastectomy.
- Presence of skin or soft-tissue conditions of the breast that may interfere with sensory assessment.
- Active smokers (use of tobacco, vape, or other nicotine products within 14 days prior to neurotization).
- Refusal or inability to attend follow-up evaluations.
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 |
|---|---|---|
| Autologous Breast Reconstruction With Direct NeurotizationThe direct neurotization using fully autologous components procedures include: 1. Direct neurotization is carried out using fully autologous components, involving coaptation of the recipient nerve to an autologous nerve graft placed within the flap to facilitate reinnervation. 2. Surgical breast reconstruction is then completed using patient's own tissue | Procedure or surgery | Neurotized Group |
| Autologous Breast Reconstruction without NeurotizationBreast reconstruction is performed using autologous tissue without nerve coaptation or neurotization, according to standard surgical practice. | Procedure or surgery | Non-Neurotized Group |
Primary outcome
Breast Sensation assessed by using Semmes-Weinstein Monofilament testing
Time frame: 1, 3 and 6 months after Neurotization
SWM thresholds at nine standardized points on the reconstructed breast will be measured using calibrated monofilaments, categorized into levels of normal touch, diminished light touch, diminished protective sensation, loss of protective sensation, and deep pressure only.
Patient's Quality of Life assessed by using BREAST-Q® Sensation Module
Time frame: 1, 3 and 6 months after Neurotization
The patient reported outcomes will be recorded in BREAST-Q® Sensation Module to capture the sensation, breast symptoms, and quality of life impact of sensation loss.
4 secondary outcomes
Neuregulin 1 Expression
Time frame: During procedure and 6 months after surgery
Nerve Cross-sectional Area
Time frame: Measured during neurotization procedure
Breast Morphometry
Time frame: Before surgery and 1, 3, 6 months after surgery
Intraepidermal Nerve Fibre Density (IENFD)
Time frame: During procedure and 6 months after surgery
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 29 Dec 2025.
- Background: PubMed 38401421Bubberman JM, Brandts L, van Kuijk SMJ, van der Hulst RRWJ, Tuinder SMH. The efficacy of sensory nerve coaptation in DIEP flap breast reconstruction - Preliminary results of a double-blind randomized controlled trial. Breast. 2024 Apr;74:103691. doi: 10.1016/j.breast.2024.103691. Epub 2024 Feb 9.
- Background: PubMed 27069510Timar B, Popescu S, Timar R, Baderca F, Duica B, Vlad M, Levai C, Balinisteanu B, Simu M. The usefulness of quantifying intraepidermal nerve fibers density in the diagnostic of diabetic peripheral neuropathy: a cross-sectional study. Diabetol Metab Syndr. 2016 Apr 11;8:31. doi: 10.1186/s13098-016-0146-4. eCollection 2016.
- Background: PubMed 40506883Samolis A, Troupis T, Politis C, Pantazis N, Triantafyllou G, Tsakotos G, Tegos T, Lazaridis N, Natsis K, Piagkou M. Intraepidermal Nerve Fiber Density as an Indicator of Neuropathy Predisposition: A Systematic Review with Meta-Analysis. Diagnostics (Basel). 2025 May 23;15(11):1311. doi: 10.3390/diagnostics15111311.
- Background: PubMed 35743534La Padula S, Pensato R, D'Andrea F, de Gregorio L, Errico C, Rega U, Canta L, Pizza C, Roccaro G, Billon R, Dibra E, Meningaud JP, Hersant B. Assessment of Patient Satisfaction Using a New Augmented Reality Simulation Software for Breast Augmentation: A Prospective Study. J Clin Med. 2022 Jun 16;11(12):3464. doi: 10.3390/jcm11123464.
- Background: PubMed 36467119Song S, Parmeshwar N, Steiner G, Kim EA. Morphometric Analysis of Gender-affirming Breast Augmentation. Plast Reconstr Surg Glob Open. 2022 Nov 29;10(11):e4691. doi: 10.1097/GOX.0000000000004691. eCollection 2022 Nov.
- Background: PubMed 38413580Bin JM, Suminaite D, Benito-Kwiecinski SK, Kegel L, Rubio-Brotons M, Early JJ, Soong D, Livesey MR, Poole RJ, Lyons DA. Importin 13-dependent axon diameter growth regulates conduction speeds along myelinated CNS axons. Nat Commun. 2024 Feb 27;15(1):1790. doi: 10.1038/s41467-024-45908-6.
- Background: PubMed 36166372Clark IA, Mohammadi S, Callaghan MF, Maguire EA. Conduction velocity along a key white matter tract is associated with autobiographical memory recall ability. Elife. 2022 Sep 27;11:e79303. doi: 10.7554/eLife.79303.
- Background: PubMed 21368034Fricker FR, Lago N, Balarajah S, Tsantoulas C, Tanna S, Zhu N, Fageiry SK, Jenkins M, Garratt AN, Birchmeier C, Bennett DL. Axonally derived neuregulin-1 is required for remyelination and regeneration after nerve injury in adulthood. J Neurosci. 2011 Mar 2;31(9):3225-33. doi: 10.1523/JNEUROSCI.2568-10.2011.
- Background: PubMed 23222914Stassart RM, Fledrich R, Velanac V, Brinkmann BG, Schwab MH, Meijer D, Sereda MW, Nave KA. A role for Schwann cell-derived neuregulin-1 in remyelination. Nat Neurosci. 2013 Jan;16(1):48-54. doi: 10.1038/nn.3281. Epub 2012 Dec 9.
- Background: PubMed 21551718Dellon ES, Crone S, Mouery R, Dellon AL. Comparison of the Semmes-Weinstein monofilaments with the Pressure-Specifying Sensory Device. Restor Neurol Neurosci. 1993 Jan 1;5(5):323-6. doi: 10.3233/RNN-1993-55602.
- Background: PubMed 31577663Voineskos SH, Klassen AF, Cano SJ, Pusic AL, Gibbons CJ. Giving Meaning to Differences in BREAST-Q Scores: Minimal Important Difference for Breast Reconstruction Patients. Plast Reconstr Surg. 2020 Jan;145(1):11e-20e. doi: 10.1097/PRS.0000000000006317.
- Background: PubMed 35749737Gallo L, Chu JJ, Shamsunder MG, Hatchell A, Patel AR, Godwin K, Hernandez M, Pusic AL, Nelson JA, Voineskos SH. Best Practices for BREAST-Q Research: A Systematic Review of Study Methodology. Plast Reconstr Surg. 2022 Sep 1;150(3):526e-535e. doi: 10.1097/PRS.0000000000009401. Epub 2022 Jun 24.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to concerns regarding participant confidentiality and the potential risk of re-identification in a small surgical trial with detailed clinical and biomarker data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Breast Reconstruction With Direct Neurotization and Autologous Breast Reconstruction without Neurotization in people with Breast Reconstruction After Mastectomy and Neurotization, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
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 6 inclusion and 5 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 29 Dec 2025. 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 Indonesia. 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?
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 Mohamad Rachadian Ramadan, MD., MRBS. (+62881082855557, rachadian@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Sensation assessed by using Semmes-Weinstein Monofilament testing (time frame: 1, 3 and 6 months after Neurotization). The study lists 2 primary outcomes in all. 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 NCT07308275, which also lists 18 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 29 Dec 2025.