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Official title Impact of Nipple Reconstruction in Mastectomized Patients Using Cross-Linked Hyaluronic Acid Injection.
ClinicalTrials.gov ID: NCT07008339
What this study is testing
- What it's testing
- This study evaluates the impact of hyaluronic acid (HA) injection for nipple projection following mastectomy, as a complement to areola micropigmentation. While micropigmentation is standard in nipple-areola complex (NAC) reconstruction, HA use remains novel, with limited data on psychosocial, sexual, and aesthetic outcomes.
- Time commitment: about 36 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Quantitative Phase
- Women over 18 years of age, or with parental or legal guardian consent. At least one of the following criteria: Women undergoing their first...
You likely can't join if
- Allergy to hyaluronic acid.
- Poor tolerance to needle injections.
- Withdrawal Criteria:
- Participant's voluntary decision.
- Complications associated with the technique (allergy, hematoma, etc.).
- Clinical deterioration preventing the woman from continuing in the study.
See the full eligibility criteria
- Quantitative Phase
- Women over 18 years of age, or with parental or legal guardian consent. At least one of the following criteria: Women undergoing their first nipple-areola complex (NAC) reconstruction through micropigmentation and/or...
- Allergy to hyaluronic acid.
- Poor tolerance to needle injections.
- Withdrawal Criteria:
- Participant's voluntary decision.
- Complications associated with the technique (allergy, hematoma, etc.).
- Clinical deterioration preventing the woman from continuing in the study.
- \- Qualitative Phase
- Participant Profile Characteristics: For the qualitative phase, women who have received NAC reconstruction with HA will be invited to participate, following the maximum variation criterion. To ensure the inclusion of...
The study team makes the final eligibility decision.
Where it's taking place
- Badalona, Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 36 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Badalona, Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.