Nipple NecrosisP4PGAMNCT06502353
Plexaa For Preconditioning: Gender Affirming Mastectomy
A study testing BLOOM43 in people with Nipple Necrosis and Nipple Graft Loss, run by Plexaa Ltd at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in transgender and non-binary patients undergoing gender affirming mastectomy. This study aims to understand a participant's experience of the device, including its usability and acceptability. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Nipple Necrosis, Nipple Graft Loss
- What is being tested?
- BLOOM43
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2025to 1 Jun 2026
- 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
- All transgender or non-binary patients over the age of 18 years (no maximum age limit)
- Patients undergoing peri-areolar mastectomy or double incision mastectomy with a free nipple graft for gender affirmation
Who cannot join
- Patients undergoing surgery for breast cancer
- Delayed (two-stage) breast reconstruction patients
- Patients undergoing simple mastectomy or wide local excision of a breast tumour
- Presence of open breast skin wounds, or infected or inflamed breast skin
- Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Division of Plastic & Reconstructive Surgery, Stanford University
Palo Alto, California, 94304
Dung Nguyen, 650-498-6004, nguyendh@stanford.edu
About this study
Official title: A Pilot Study to Investigate the Use of the Plexaa Preconditioning Device (BLOOM43) for Gender Affirming Mastectomy - a Prospective Cohort Study
The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in transgender and non-binary patients undergoing gender affirming mastectomy. This study aims to understand a participant's experience of the device, including its usability and acceptability.
Participants will use the device to precondition their right breast the evening before undergoing surgery (gender affirming mastectomy).
- Conditions
- Nipple Necrosis, Nipple Graft Loss
- Being tested
- BLOOM43
- Keywords
- Nipple necrosis, Nipple graft loss, Preconditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLOOM43Device
Also called Plexaa preconditioning device
Heat preconditioning
| Study group | Role | What they receive |
|---|---|---|
| All participants (single arm) | Experimental | Each patient will be given the device, BLOOM43, for use at home. It will be worn in a patient's existing bra over their right breast and the preconditioning protocol will be done 12 hours before surgery - i.e. the evening before. Patients will then attend their breast surgery the next day as planned. Receives: Device: BLOOM43 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant experience
Participants' experience of the device will be evaluated with the use of a questionnaire. Most of the questions will consist of multiple-choice components with a five-point scale and there will also be a section for further comments from participants.
Measured: 30 days
Secondary outcomes (2)
Compliance
Proportion of participants who are compliant with the preconditioning protocol
Measured: 1 day
Nipple necrosis/nipple graft loss
Proportion of participants experiencing partial or complete nipple necrosis/nipple graft loss and the rate of hospital readmission due to this
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start20 Aug 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nipple NecrosisStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Plexaa Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Dung Nguyen, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502353
- Sponsor's protocol ID
- 75139
- Other IDs
- Pro00074534
- Acronym
- P4PGAM
- Status last verified
- Sep 2025
- First submitted
- 26 Jun 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meerwijk EL, Sevelius JM. Transgender Population Size in the United States: a Meta-Regression of Population-Based Probability Samples. Am J Public Health. 2017 Feb;107(2):e1-e8. doi: 10.2105/AJPH.2016.303578.
PubMed 28075632Rifkin WJ, Robinson IS, Kloer C, Cripps CN, Boyd CJ, Blasdel G, Zhao LC, Bluebond-Langner R. Gender-affirming Mastectomy: Comparison of Periareolar and Double Incision Patterns. Plast Reconstr Surg Glob Open. 2022 May 25;10(5):e4356. doi: 10.1097/GOX.0000000000004356. eCollection 2022 May.
PubMed 35646495Perez-Alvarez IM, Zolper EG, Schwitzer J, Fan KL, Del Corral GA. Incidence of Complications in Chest Wall Masculinization for the Obese Female-to-Male Transgender Population: A Case Series. World J Plast Surg. 2021 May;10(2):14-24. doi: 10.29252/wjps.10.2.14.
PubMed 34307093Kankam HKN, Mehta S, Jain A. Thermal Preconditioning for Surgery: A Systematic Review. J Plast Reconstr Aesthet Surg. 2020 Sep;73(9):1645-1664. doi: 10.1016/j.bjps.2020.05.025. Epub 2020 May 21.
PubMed 32505626Mehta S, Rolph R, Cornelius V, Harder Y, Farhadi J. Local heat preconditioning in skin sparing mastectomy: a pilot study. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1676-82. doi: 10.1016/j.bjps.2013.07.034. Epub 2013 Sep 4.
PubMed 24011908Mehta S, Cro SC, Coomber B, Rolph R, Cornelius V, Farhadi J. A randomised controlled feasibility trial to evaluate local heat preconditioning on wound healing after reconstructive breast surgery: the preHEAT trial. Pilot Feasibility Stud. 2019 Jan 11;5:5. doi: 10.1186/s40814-019-0392-y. eCollection 2019.
PubMed 30656059
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate the Use of the Plexaa Preconditioning Device (BLOOM43) for Gender Affirming Mastectomy - a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06502353
- Acronym / sponsor ID
- P4PGAM / 75139
- Conditions
- Nipple Necrosis, Nipple Graft Loss
- Keywords
- Nipple necrosis, Nipple graft loss, Preconditioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Plexaa LtdIndustry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 16 Jul 2024 (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.
The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in transgender and non-binary patients undergoing gender affirming mastectomy. This study aims to understand a participant's experience of the device, including its usability and acceptability.
Participants will use the device to precondition their right breast the evening before undergoing surgery (gender affirming mastectomy).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants (single arm) | Experimental | Device: BLOOM43Each patient will be given the device, BLOOM43, for use at home. It will be worn in a patient's existing bra over their right breast and the preconditioning protocol will be done 12 hours before surgery - i.e. the evening before. Patients will then attend their breast surgery the next day as planned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All transgender or non-binary patients over the age of 18 years (no maximum age limit)
- Patients undergoing peri-areolar mastectomy or double incision mastectomy with a free nipple graft for gender affirmation
Key exclusion criteria (5 listed)
- Patients undergoing surgery for breast cancer
- Delayed (two-stage) breast reconstruction patients
- Patients undergoing simple mastectomy or wide local excision of a breast tumour
- Presence of open breast skin wounds, or infected or inflamed breast skin
- Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device
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 |
|---|---|---|
| BLOOM43Also: Plexaa preconditioning deviceHeat preconditioning | Device | All participants (single arm) |
Primary outcome
Participant experience
Time frame: 30 days
Participants' experience of the device will be evaluated with the use of a questionnaire. Most of the questions will consist of multiple-choice components with a five-point scale and there will also be a section for further comments from participants.
2 secondary outcomes
Compliance
Time frame: 1 day
Nipple necrosis/nipple graft loss
Time frame: 30 days
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 1 Oct 2025.
- Background: PubMed 28075632Meerwijk EL, Sevelius JM. Transgender Population Size in the United States: a Meta-Regression of Population-Based Probability Samples. Am J Public Health. 2017 Feb;107(2):e1-e8. doi: 10.2105/AJPH.2016.303578.
- Background: PubMed 35646495Rifkin WJ, Robinson IS, Kloer C, Cripps CN, Boyd CJ, Blasdel G, Zhao LC, Bluebond-Langner R. Gender-affirming Mastectomy: Comparison of Periareolar and Double Incision Patterns. Plast Reconstr Surg Glob Open. 2022 May 25;10(5):e4356. doi: 10.1097/GOX.0000000000004356. eCollection 2022 May.
- Background: PubMed 34307093Perez-Alvarez IM, Zolper EG, Schwitzer J, Fan KL, Del Corral GA. Incidence of Complications in Chest Wall Masculinization for the Obese Female-to-Male Transgender Population: A Case Series. World J Plast Surg. 2021 May;10(2):14-24. doi: 10.29252/wjps.10.2.14.
- Background: PubMed 32505626Kankam HKN, Mehta S, Jain A. Thermal Preconditioning for Surgery: A Systematic Review. J Plast Reconstr Aesthet Surg. 2020 Sep;73(9):1645-1664. doi: 10.1016/j.bjps.2020.05.025. Epub 2020 May 21.
- Background: PubMed 24011908Mehta S, Rolph R, Cornelius V, Harder Y, Farhadi J. Local heat preconditioning in skin sparing mastectomy: a pilot study. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1676-82. doi: 10.1016/j.bjps.2013.07.034. Epub 2013 Sep 4.
- Background: PubMed 30656059Mehta S, Cro SC, Coomber B, Rolph R, Cornelius V, Farhadi J. A randomised controlled feasibility trial to evaluate local heat preconditioning on wound healing after reconstructive breast surgery: the preHEAT trial. Pilot Feasibility Stud. 2019 Jan 11;5:5. doi: 10.1186/s40814-019-0392-y. eCollection 2019.
- Individual participant dataSharing planned: No
Related trials for Nipple Necrosis
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.
Dung Nguyen principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BLOOM43 in people with Nipple Necrosis and Nipple Graft Loss, run by Plexaa Ltd at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 1 Oct 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 United States. 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 Saahil Mehta (447711183551, saahil@plexaa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant experience (time frame: 30 days). 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 NCT06502353, which also lists 6 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 1 Oct 2025.