The Impact of Adipose Tissue Quality on Fat Graft RetentionLipoTechNCT05286424
Lipofilling: Optimal Harvesting Techniques for Breast Reconstruction After Mastectomy in Plastic Aesthetic and Reconstructive Surgery
A study testing fat grafting in people with The Impact of Adipose Tissue Quality on Fat Graft Retention, run by Medical University of Graz at 1 site in Austria.
Trial summary
The primary aim of this project is to standardize the method for lipofilling by identifying the best technique. In this context, the study will investigate the impact of adipose tissue composition and ideal quantity of the injected fat particularly in view of resorption rate. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- The Impact of Adipose Tissue Quality on Fat Graft Retention
- What is being tested?
- fat grafting
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- 15 Feb 2021to 10 Jul 2022
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women, age 18-70 years (limited upwards due to the indication for lipofilling and the amount of possible secondary diseases)
- History of BRCA1 and BRCA2 - positive breast cancer with following subcutaneous mastectomy
- Planned, elective breast-lipofilling
- Thickness of the skin and subcutaneous fat layer of min. 1 cm (detected via sonography)
- Currently healthy individual, willing to participate in this study
Who cannot join
- Previous surgery at the harvesting site (e.g. caesarian section)
- Pregnancy or planned pregnancy
- Current or preceded chemotherapy
- Preceded radiatio
- Unable to fully understand study procedures and to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lipofilling: Optimal Harvesting Techniques for Breast Reconstruction After Mastectomy in Plastic Aesthetic and Reconstructive Surgery - a Pilot Study
The primary aim of this project is to standardize the method for lipofilling by identifying the best technique. In this context, the study will investigate the impact of adipose tissue composition and ideal quantity of the injected fat particularly in view of resorption rate. Correlations between adipose tissue composition, amount of transferred fat, already existing subcutaneous fat layer at the grafting site and resorption rate will be made.
The punch biopsy and the non-invasive Lipometer measurements to determine the subcutaneous fat layer thickness in the harvesting and grafting region will be performed in 10 female subjects that undergo elective lipofilling.
The study was registered on Clinicaltrials.gov after start of recruitment.
- Being tested
- fat grafting
- Keywords
- fat graft, adipose tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fat graftingProcedure or surgery
Also called lipofilling
Fat will be removed from abdomen or legs, processed and re-injected into grafting sites.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose tissue dependent take rate
Detect an adipose tissue composition-dependent take rate
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start15 Feb 2021
- Primary completion28 Jul 2021
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Impact of Adipose Tissue Quality on Fat Graft RetentionStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Joanneum Research Forschungsgesellschaft mbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286424
- Sponsor's protocol ID
- 32-487 ex 19/20
- Acronym
- LipoTech
- Status last verified
- Aug 2022
- First submitted
- 9 Mar 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipofilling: Optimal Harvesting Techniques for Breast Reconstruction After Mastectomy in Plastic Aesthetic and Reconstructive Surgery - a Pilot Study
- ClinicalTrials.gov ID
- NCT05286424
- Acronym / sponsor ID
- LipoTech / 32-487 ex 19/20
- Keywords
- fat graft, adipose tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Joanneum Research Forschungsgesellschaft mbH
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 18 Mar 2022 (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 primary aim of this project is to standardize the method for lipofilling by identifying the best technique. In this context, the study will investigate the impact of adipose tissue composition and ideal quantity of the injected fat particularly in view of resorption rate. Correlations between adipose tissue composition, amount of transferred fat, already existing subcutaneous fat layer at the grafting site and resorption rate will be made.
The punch biopsy and the non-invasive Lipometer measurements to determine the subcutaneous fat layer thickness in the harvesting and grafting region will be performed in 10 female subjects that undergo elective lipofilling.
The study was registered on Clinicaltrials.gov after start of recruitment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women, age 18-70 years (limited upwards due to the indication for lipofilling and the amount of possible secondary diseases)
- History of BRCA1 and BRCA2 - positive breast cancer with following subcutaneous mastectomy
- Planned, elective breast-lipofilling
- Thickness of the skin and subcutaneous fat layer of min. 1 cm (detected via sonography)
- Currently healthy individual, willing to participate in this study
Key exclusion criteria (5 listed)
- Previous surgery at the harvesting site (e.g. caesarian section)
- Pregnancy or planned pregnancy
- Current or preceded chemotherapy
- Preceded radiatio
- Unable to fully understand study procedures and to provide informed consent
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 |
|---|---|---|
| fat graftingAlso: lipofillingFat will be removed from abdomen or legs, processed and re-injected into grafting sites. | Procedure or surgery | – |
Primary outcome
Adipose tissue dependent take rate
Time frame: 12-24 months
Detect an adipose tissue composition-dependent take rate
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 25 Aug 2022.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fat grafting in people with The Impact of Adipose Tissue Quality on Fat Graft Retention, run by Medical University of Graz at 1 site in Austria.
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 5 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: finished, as of the sponsor's last update on 25 Aug 2022. 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 Austria. 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?
Adipose tissue dependent take rate (time frame: 12-24 months). 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 25 Aug 2022.