Breast Reconstruction After MastectomyPRO-PocketNCT03868514
Post Market Clinical Follow Up to "Patient Reported Outcome" Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)
An observational study of Breast Reconstruction After Mastectomy and Breast Neoplasm, run by pfm medical gmbh at 12 sites in 2 countries.
Trial summary
"PRO-Pocket" - International prospective multicentre Post Market Clinical Follow Up to "Patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra Pocket) Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Reconstruction After Mastectomy, Breast Neoplasm, Breast Cancer
- What is being tested?
- TiLOOP® Bra Pocket
- Type of treatment
- Medical device
- How many people
- 313 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 4 Jul 2019to 15 Nov 2023
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with indicated implant based breast reconstruction after mastectomy.
Who may be able to join
- Age [≥ 18]
- Indications of breast reconstruction: histologically confirmed breast cancer, precancerous lesions (DCIS, LCIS), mutation carrier with increased breast cancer risk, strong family history (lifetime risk > 15%)
- The patient is capable to realise the nature, aims and possible consequences of the clinical trial (MPG §20.2.1)
- Patient information has been provided and all written consents of the patient are available
Who cannot join
- Metastatic breast cancer
- Patient with known contraindications against mesh-assisted or plastic-reconstructive breast surgery according to the instruction for use
- Patient is kept in an institution under judicial or official orders (MPG §20.3)
- Participate in another operative clinical trial, if it relates to the area of reconstructive breast surgery and/or influences the primary endpoint of the clinical trial
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Germany11 sites
Vivantes Klinikum Am Urban
Berlin, 10967
DRK Kliniken Westend
Berlin, 14050
Universitätsklinikum Bonn
Bonn, 53127
Kliniken Essen Mitte; Evang. Huyssens-Stiftung
Essen, 45136
Agaplesion Markus Krankenhaus
Frankfurt, 60431
Universitätsmedizin Greifswald
Greifswald, 17475
Universitätsklinikum Heidelberg
Heidelberg, 69120
Rotkreuzklinikum München
Munich, 80637
Klinikum rechts der Isar der Technischen Universität München
Munich, 81675
Universitätsklinikum Ulm
Ulm, 89075
GRN Klinik Weinheim
Weinheim
Austria1 site
Universitätsklinik für Frauenheilkunde, Allgemeines Krankenhaus der Stadt Wien
Vienna, 1090
About this study
Official title: "PRO-Pocket" - International Prospective Multicenter Post Market Clinical Follow Up to "Patient Reported Outcome" in Primary or Secondary Breast Reconstruction After Mastectomy Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)
"PRO-Pocket" - International prospective multicentre Post Market Clinical Follow Up to "Patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra Pocket)
Read the detailed description
This international, multicentre, non-randomised, observational clinical device investigation will be performed to obtain post market information on TiLOOP® Bra Pocket surgical meshes for a period of up to two years. In particular, on patient reported satisfaction (BreastQTM), cosmetic outcome and the rate of complications.
The objective of the clinical Investigation is to establish the efficacy and safety of the TiLOOP® Bra Pocket.
The Investigation will be performed in ten clinical centres in Germany and Austria.
- Being tested
- TiLOOP® Bra Pocket
- Keywords
- breast reconstruction, surgical mesh, synthetic mesh, patient reported outcome, breast cancer, mesh
- Medical subject headings
- Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiLOOP® Bra PocketDevice
Primary or secondary breast reconstruction following mastectomy with titanised polypropylene mesh TiLOOP® Bra Pocket
| Study group | Role | What they receive |
|---|---|---|
| TiLOOP Bra Pocket | Medical Device Receives: Device: TiLOOP® Bra Pocket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life - Patient reported outcome
The primary endpoint is defined as the change of the four BreastQ domain scores before study treatment compared to twelve months after study treatment. The BreastQ questionnaire yields a domain score in the range from zero to 100. Wheras a score of 100 is the best score. The study hypothesis is that the patient's QoL after the study intervention treatment is not worse than the QoL prior to the intervention study treatment . The following four domains are relavant: Satisfaction with breasts, Psychosocial well-being, Physical well-being:chest and Sexual well-being.
Measured: 12 months after study treatment
Secondary outcomes (3)
Quality of Life - Patient reported outcome
The change of the four BreastQ domain scores before study treatment compared to six months and 24 months after study treamtment.
Measured: 6 and 24 months after study treatment
Complication rate
The number and rate of occurrence of adverse events is reported as a secondary endpoint along with a tabulation of the types of adverse events (6, 12 and 24 months after study treatment).
Measured: 6, 12 and 24 months after study treatment
Cosmetic outcome
The cosmetic outcome is assessed based on photographs 6, 12 and 24 months after study treatment by descriptive statistics (an independent expert, the physician in charge and the patient assess the cosmetic outcome).
Measured: 6, 12 and 24 months after study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start4 Jul 2019
- Primary completion22 Jun 2022
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Reconstruction After MastectomyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- pfm medical gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868514
- Sponsor's protocol ID
- P050001 TiLOOP® Bra Pocket
- Acronym
- PRO-Pocket
- Status last verified
- Nov 2023
- First submitted
- 6 Mar 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "PRO-Pocket" - International Prospective Multicenter Post Market Clinical Follow Up to "Patient Reported Outcome" in Primary or Secondary Breast Reconstruction After Mastectomy Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)
- ClinicalTrials.gov ID
- NCT03868514
- Acronym / sponsor ID
- PRO-Pocket / P050001 TiLOOP® Bra Pocket
- Keywords
- breast reconstruction, surgical mesh, synthetic mesh, patient reported outcome, breast cancer, mesh
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- pfm medical gmbhIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 11 Mar 2019 (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.
"PRO-Pocket" - International prospective multicentre Post Market Clinical Follow Up to "Patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra Pocket)
Detailed description
This international, multicentre, non-randomised, observational clinical device investigation will be performed to obtain post market information on TiLOOP® Bra Pocket surgical meshes for a period of up to two years. In particular, on patient reported satisfaction (BreastQTM), cosmetic outcome and the rate of complications.
The objective of the clinical Investigation is to establish the efficacy and safety of the TiLOOP® Bra Pocket.
The Investigation will be performed in ten clinical centres in Germany and Austria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TiLOOP Bra Pocket | – | Device: TiLOOP® Bra PocketMedical Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with indicated implant based breast reconstruction after mastectomy.
Key inclusion criteria (4 listed)
- Age [≥ 18]
- Indications of breast reconstruction: histologically confirmed breast cancer, precancerous lesions (DCIS, LCIS), mutation carrier with increased breast cancer risk, strong family history (lifetime risk > 15%)
- The patient is capable to realise the nature, aims and possible consequences of the clinical trial (MPG §20.2.1)
- Patient information has been provided and all written consents of the patient are available
Key exclusion criteria (4 listed)
- Metastatic breast cancer
- Patient with known contraindications against mesh-assisted or plastic-reconstructive breast surgery according to the instruction for use
- Patient is kept in an institution under judicial or official orders (MPG §20.3)
- Participate in another operative clinical trial, if it relates to the area of reconstructive breast surgery and/or influences the primary endpoint of the clinical trial
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 |
|---|---|---|
| TiLOOP® Bra PocketPrimary or secondary breast reconstruction following mastectomy with titanised polypropylene mesh TiLOOP® Bra Pocket | Device | TiLOOP Bra Pocket |
Primary outcome
Quality of Life - Patient reported outcome
Time frame: 12 months after study treatment
The primary endpoint is defined as the change of the four BreastQ domain scores before study treatment compared to twelve months after study treatment. The BreastQ questionnaire yields a domain score in the range from zero to 100. Wheras a score of 100 is the best score. The study hypothesis is that the patient's QoL after the study intervention treatment is not worse than the QoL prior to the intervention study treatment . The following four domains are relavant: Satisfaction with breasts, Psychosocial well-being, Physical well-being:chest and Sexual well-being.
3 secondary outcomes
Quality of Life - Patient reported outcome
Time frame: 6 and 24 months after study treatment
Complication rate
Time frame: 6, 12 and 24 months after study treatment
Cosmetic outcome
Time frame: 6, 12 and 24 months after study treatment
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 18 Nov 2023.
- pfm medical study informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Reconstruction After Mastectomy and Breast Neoplasm, run by pfm medical gmbh at 12 sites in 2 countries.
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 4 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, 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?
Quality of Life - Patient reported outcome (time frame: 12 months after study treatment). 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 18 Nov 2023.