Breast NeoplasmsNCT03744273
Capsule Biopsy in Acellular Dermal Matrix-based Prosthetic Breast Reconstruction: a Prospective Pilot Study
A study testing breast capsule biopsy in people with Breast Neoplasms and Mammaplasty, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
In this prospective study, breast capsule biopsy was performed in patients undergoing 2-stage expander-implant breast reconstruction to determine its use. Prospective clinical trial was designed for 10 consecutive patients as a pilot study and approved by IRB of Samsung Medical Center. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms, Mammaplasty, Acellular Dermis
- What is being tested?
- breast capsule biopsy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- 3 Nov 2013to 26 May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 70 years
- Women only
- Adult, Older adult
Who may be able to join
- age between 20 and 70
- planning 2-stage expander-implant breast reconstruction using acellular dermal matrix
- with no medical history such as diabetes, hypertension, or smoking
- no surgical history
Who cannot join
- pregnant
- newly detected medical or surgical condition
- acellular dermal matrix loss due to allergic reaction or prosthetic infection
- breast cancer recurrence
- transfer to other institution
- reconstruction give-up due to patient's wish
- no biopsy score
Trial locations and contacts
1 site in 1 country.
About this study
In this prospective study, breast capsule biopsy was performed in patients undergoing 2-stage expander-implant breast reconstruction to determine its use. Prospective clinical trial was designed for 10 consecutive patients as a pilot study and approved by IRB of Samsung Medical Center. From November 2013 to May 2015, full-thickness capsule biopsy specimen was obtained from acellular dermal matrix (ADM) capsule and from native subpectoral capsule (internal control) during expander-implant exchange. Biopsy specimens were scored for fibrosis and inflammatory reactions.
This is completed study and its specific title, study objective, method, and results will be available online after scientific journal submission.
- Conditions
- Breast Neoplasms, Mammaplasty, Acellular Dermis
- Being tested
- breast capsule biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast capsule biopsyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
histology scoring
semiquantitative histopathologic score system of biopsy specimens (reference: Basu et al., Plastic and Reconstructive Surgery, 126: 1842, 2010)
Measured: immediate after biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start3 Nov 2013
- Primary completion26 May 2015
- Study completion26 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jai-Kyong Pyon, Samsung Medical Center
- Investigators
- Jai-Kyong Pyon, MD,PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744273
- Sponsor's protocol ID
- 2012-03-028
- Status last verified
- Nov 2018
- First submitted
- 14 Nov 2018
- Last updated
- 19 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsule Biopsy in Acellular Dermal Matrix-based Prosthetic Breast Reconstruction: a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT03744273
- Acronym / sponsor ID
- 2012-03-028
- Conditions
- Breast Neoplasms, Mammaplasty, Acellular Dermis
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 3 Nov 2013 (actual)
- Primary completion
- 26 May 2015 (actual)
- Study completion
- 26 May 2015 (actual)
- First posted
- 16 Nov 2018 (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.
In this prospective study, breast capsule biopsy was performed in patients undergoing 2-stage expander-implant breast reconstruction to determine its use. Prospective clinical trial was designed for 10 consecutive patients as a pilot study and approved by IRB of Samsung Medical Center. From November 2013 to May 2015, full-thickness capsule biopsy specimen was obtained from acellular dermal matrix (ADM) capsule and from native subpectoral capsule (internal control) during expander-implant exchange. Biopsy specimens were scored for fibrosis and inflammatory reactions.
This is completed study and its specific title, study objective, method, and results will be available online after scientific journal submission.
Study design
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 20 and 70
- planning 2-stage expander-implant breast reconstruction using acellular dermal matrix
- with no medical history such as diabetes, hypertension, or smoking
- no surgical history
Key exclusion criteria (7 listed)
- pregnant
- newly detected medical or surgical condition
- acellular dermal matrix loss due to allergic reaction or prosthetic infection
- breast cancer recurrence
- transfer to other institution
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 |
|---|---|---|
| breast capsule biopsy | Procedure or surgery | – |
Primary outcome
histology scoring
Time frame: immediate after biopsy
semiquantitative histopathologic score system of biopsy specimens (reference: Basu et al., Plastic and Reconstructive Surgery, 126: 1842, 2010)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
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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. This study is not recruiting at the moment.
Jai-Kyong Pyon, MD,PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breast capsule biopsy in people with Breast Neoplasms and Mammaplasty, run by Samsung Medical Center at 1 site in South Korea.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 19 Nov 2018. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
histology scoring (time frame: immediate after biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2018; AzTrials last refreshed its copy on 2 Nov 2026.