Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

TiLOOP Bra

Stefan Paepke, MD

This multicentre, non-randomised, observational clinical device investigation will be performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the improvement of the patients' quality of life as well as on the rate of complications of the device under investigation.

The objective of this clinical investigation is to establish the feasibility, efficacy and safety of the TiLOOP® Bra.

National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra

National, Multicenter Post-market Surveillance Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiLOOP Bra)

Measurement of the Patient Reported Outcome (PRO).

Measurement of the Patient Reported Outcome

Complication rate of the first 60 patients in the 6 month follow-up and of all patients after 6, 12 and 24 months.

Cosmetic success confirming the reinforcement will be assessed by the patient and an independent professional at a photo. The questions posed are part of the validated Breast Q questionnaire.

Measurement of the Patient Reported Outcome and complication rate of all patients

pfm medical gmbh

Pfm Medical Mepro Gmbh

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Syndrome

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hereditary Breast and Ovarian Cancer Syndrome

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Breast Diseases

Skin Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

immediate breast reconstruction with an implant and TiLoop Bra

immediate breast reconstruction with an implant and Protexa

TiLoop Bra

Protexa

Daphne Gschwantler-Kaulich, Ass.Prof.Dr.

Randomized controlled trial to look at early complications, cosmetic outcome, patient satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast cancer centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.

Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study

hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss

four point Harris Scale (1=poor, 4=excellent)

The thickness of the tissue covering the implant in the lower pole im mm measured by ultrasound

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra	NCT01885572	Breast Reconstr...	TiLOOP Bra	18 Years - 70 Years	Pfm Medical Mepro Gmbh
Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study	NCT02562170	Breast Cancer Hereditary Brea...	TiLoop Bra Protexa	18 Years - 75 Years	Medical University of Vienna
Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study	NCT02562170	Breast Cancer Hereditary Brea...	TiLoop Bra Protexa	18 Years - 75 Years	Medical University of Vienna
National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra	NCT01885572	Breast Reconstr...	TiLOOP Bra	18 Years - 70 Years	Pfm Medical Mepro Gmbh

Spots Global Cancer Trial Database for tiloop bra

Every month we try and update this database with for tiloop bra cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tiloop bra

Every month we try and update this database with for tiloop bra cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tiloop bra cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.