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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03197103 |
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Date of registration:
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21/06/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Impact of N-Acetylcysteine on Volumetric Retention of Autologous Fat Graft for Breast Asymmetry Correction
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Scientific title:
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The Impact of N-Acetylcysteine on Volumetric Retention of Autologous Fat Graft for Breast Asymmetry Correction |
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Date of first enrolment:
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July 4, 2017 |
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Target sample size:
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15 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03197103 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Poland
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Contacts
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Name:
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Bartlomiej Noszczyk, Ph.D., M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre of Postgraduate Medical Education |
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Name:
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Piotr Pietruski, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre of Postgraduate Medical Education |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female
- Age 18-40 years
- BMI > 20
- Breasts asymmetry (including tuberous breasts deformity) with indications for
treatment with autologous fat grafting
- ASA PS I
Exclusion Criteria:
- Asthma
- A history of allergic reaction to NAC
- Peptic ulcer disease
- Contraindications to MRI imaging
- A history of breast surgery or radiotherapy
- A history of hip/thigh surgery or injury
- Breastfeeding, pregnancy or planned pregnancy within a year
- Ilness or general state of health precluding general anesthesia
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Adipose Tissue Atrophy
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Breast; Deformity, Congenital
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Breast; Atrophy
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Graft Loss
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Intervention(s)
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Drug: N-Acetylcysteine (NAC)
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Primary Outcome(s)
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Autologous fat graft volumetric analysis
[Time Frame: 6 months following the intervention in the last enrolled participant]
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Secondary Outcome(s)
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Immunohistochemical and genetic analysis of lipoaspirates.
[Time Frame: Immediately after intervention]
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Intraoperative complications
[Time Frame: During intervention (operation)]
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Postoperative complications
[Time Frame: 6 months following the intervention]
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Secondary ID(s)
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58/IX/PB/Noszczyk/16
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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