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Breast Reconstruction clinical trials

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NCT ID: NCT06274736 Recruiting - Clinical trials for Breast Reconstruction

Safety and Performance of Motiva® Sizers

Start date: April 10, 2023
Phase:
Study type: Observational

The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures. The research will include 330 women, divided into two groups of 165 participants each (150 breast augmentation participants and 15 reconstruction participants). The Motiva® Sizer exposed group will consist of women who will undergo breast augmentation or reconstruction surgery with the use of Motiva® Sizer during the procedure, and a non-exposed group will consist of women who will undergo breast augmentation or reconstruction surgery without the use of Motiva® Sizer. This study will be conducted in Costa Rica. The main goal is to evaluate the safety and the performance of the Motiva® Sizer. To this end, the results of both groups will be compared in terms of surgical complications, surgeon's, and participant's satisfaction level as well as reoperation rates. After the augmentation or reconstruction surgery, participants will be scheduled for the following follow-up visits, (1) between 3 and 7 postoperative days, (2) between 3 and 6 postoperative weeks, (3) at 3 and (4) 6 postoperative months, and (5, 6 and 7) annually thereafter for a period of three consecutive years. In case any participant has an adverse event due to the procedure, and if required by the physician, an additional visit will be made to assess her, and this information as well as that of the scheduled visits should be recorded in the electronic data collection notebook.

NCT ID: NCT05710705 Recruiting - Clinical trials for Breast Reconstruction

Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction

MONITRANS2
Start date: December 8, 2022
Phase: N/A
Study type: Interventional

As the occurrence of thrombosis in post surgery is rare, it seemed difficult to study only this one. This is why we decided to test the bioimpedance, temperature and green, red and infrared light absorption measurements of the prototype during the weaning of the flap during surgery. Indeed, during weaning the investigators voluntarily interrupt the arterial and venous flow to transfer the flap to the breast. This weaning corresponds to a thrombosis model. The patients will benefit from an "improved" postoperative monitoring. Indeed, in addition to the classical clinical monitoring, they will benefit from an additional monitoring during 5 days thanks to the realization of an ultrasound of the flap which will be carried out every 6 hours the first 24 hours then every 12 hours. This protocol is therefore a feasibility study for the collection of data of interest.

NCT ID: NCT05585710 Recruiting - Clinical trials for Breast Reconstruction

Pulsed Lavage in Implant-Based Breast Reconstruction

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

To determine if there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction. Primary outcomes will include post-op complications including surgical site infection (SSI), hematoma, seroma, and implant failure.

NCT ID: NCT05460780 Recruiting - Clinical trials for Breast Cancer Female

First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer

TIDE
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

This study is a first in human, two-stage single arm non-comparative study of safety and performance. The aim of the study is to asses the safety and the clinical performance of a new device : the MATTISSE tissu engineering chamber.

NCT ID: NCT05377723 Recruiting - Clinical trials for Breast Reconstruction

Abdominal Scar Improvement in Microsurgical Breast Reconstruction

Start date: October 31, 2022
Phase: N/A
Study type: Interventional

Microsurgical breast reconstruction is most commonly performed with free abdominal flaps, which leave a long transverse lower abdominal scar. Due to tension across the incision, these scars frequently widen and hypertrophy. Hence, modalities that can reduce this tendency, thus, improving scar appearance are desirable. Here, we wish to investigate the impact of the Neodyne embrace device on postoperative abdominal scar appearance. The proposed study is novel in that it is the first RCT investigating the effect of the embrace device on scar appearance in the context of microsurgical breast reconstruction.

NCT ID: NCT05363189 Recruiting - Breast Cancer Clinical Trials

Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)

BestDIEP
Start date: May 2, 2022
Phase:
Study type: Observational

Women who have their breast reconstructed with autologous tissue seem to be more satisfied with their breast. However, autologous breast reconstruction entails a bigger operation, and the usage of more health care resources, than some other methods, such as implant-based techniques. The main objectives of the present study are to investigate if pre- peri- and postoperative protocols can be safely modified, so the operation demands less resources, while maintaining a low complication rate and a high patient satisfaction.

NCT ID: NCT04967976 Recruiting - Breast Cancer Clinical Trials

Breast Mesh Used in Two-staged Breast Reconstruction

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.

NCT ID: NCT04891510 Recruiting - Clinical trials for Breast Reconstruction

A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery

Start date: May 19, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to learn whether there is a superior fat processing method in terms of graft retention in breast reconstruction after mastectomy.

NCT ID: NCT04888351 Recruiting - Breast Cancer Clinical Trials

Immediate Breast Reconstruction's Increasing

IBRI
Start date: January 1, 2021
Phase:
Study type: Observational

Mastectomy in breast cancer is still a way of treatment. Nowadays, the goal is to improve reconstruction's technicals. Immediate Breast Reconstruction (IBR) is one of them, largely used in United States but less in France. However, IGR (Insitut Gustave Roussey) in Paris just wrote a new protocole wich allows more IBR by including more patients. This study aims to compare complications in 2 groups: mastectomies followed by IBR and mastectomies without IBR. The second goal will try to estimate the proportion of eligible's patients to IBR, and to analyse their surgicals and oncologicals risk factors

NCT ID: NCT04860843 Recruiting - Nerve Block Clinical Trials

Nerve Blocks in Alloplastic Breast Reconstruction

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

Pain management is a major concern in oncologic breast surgery and reconstruction. Significant risks for acute and chronic pain after surgery might be reduced through improved pain control pre-operatively. Addition of regional anesthesia to a multimodal peri-operative pain management protocol offers a promising solution for improved recovery. For patients undergoing mastectomy with immediate alloplastic breast reconstruction, this RCT compares TPVB+Pecs local anesthetic block with TPVB local anesthetic block and Pecs placebo normal saline block for their effect on acute pain, chronic pain, opioid consumption, opioid-related side effects, patient-reported quality of recovery after surgery, and length of stay.