Clinical trials: Reconstruction Surgery
Digital Nerve Injury, Nerve Injury
Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries
The goal of this clinical study is to evaluate if a period of electrical stimulation delivered during the surgical repair procedure can speed up nerve healing.
- Conditions
- Digital Nerve Injury, Nerve Injury, Nerve Reconstruction, Nerve Trauma
- Trial name
- FASTR-TEN (NCT06867185)
- Testing
- Brief Electrical Stimulation Therapy, Digital Nerve Repair
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Checkpoint Surgical Inc.
Breast Augmentation and Breast Reconstruction, Mammaplasty
Clinical Study on Tissue Preservation in Breast Augmentation and Reconstruction
This clinical study aims to evaluate the safety and effectiveness of advanced, minimally invasive techniques for breast augmentation and reconstruction.
- Conditions
- Breast Augmentation and Breast Reconstruction, Mammaplasty, Breast Augmentation, Tissue Preservation
- Trial name
- NCT07623564
- Testing
- Mia Harmonization, Mia Scarless Lift, Mia Reconstruction
- Where
- Costa Rica
- Volunteers
- 60 people
- Sponsor
- Establishment Labs
Mandibular Fractures, Facial Fracture
Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up
A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the clinical setting.
- Conditions
- Mandibular Fractures, Facial Fracture, Maxilla Fracture, Orthognathic Surgical Procedures
- Trial name
- UPC (NCT07245810)
- Testing
- Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery
- Where
- 2 sites in United States
- Volunteers
- 726 people
- Sponsor
- Stryker Craniomaxillofacial
Congenital Heart Disease, Cardiac Anomaly
Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium in Cardiac Repair or Reconstruction Surgery
The objective of this postmarket, retrospective, single center study is to evaluate the clinical outcomes of patients who have received PhotoFix® Decellularized Bovine Pericardium (PhotoFix) as a patch within a cardiac surgical…
- Trial name
- Retro-C (NCT05314868)
- Testing
- PhotoFix
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Artivion Inc.
Pelvic Organ Prolapse
Post-market Clinical Follow-up of the SRS Implant
National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant
- Trial name
- NCT05170074
- Where
- 6 sites in Germany
- Volunteers
- 97 people
- Sponsor
- pfm medical gmbh
Breast Reconstruction
Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction
The objective of this study is to prospectively observe clinical and economic outcomes with the use of SERI® in direct-to-implant breast reconstruction.
- Trial name
- NCT02033590
- Testing
- Biodegradable (purified) surgical silk scaffold
- Sponsor
- Sofregen Medical, Inc.
Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy
BIOCHROMADERM® PMCF STUDY
The goal of this observational study is to: To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation; To confirm the…
- Trial name
- NCT07261904
- Where
- 3 sites in France
- Volunteers
- 115 people
- Sponsor
- Laboratoires BIOTIC Phocea
Macromastia
Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures
This is a prospective, controlled, randomized, multi-center clinical study of up to 80 patients with full thickness surgical incisions associated with bi-lateral breast procedures.
- Trial name
- NCT00558246
- Testing
- Dermabond Protape (Prineo), Suture
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 79 people
- Sponsor
- Ethicon, Inc.
Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction
Impact of ADM in Reduction of Surgical Complexity of Breast Reconstructions With Implants (Nava)
The objective of this study is to demonstrate that acellular dermal matrix, Strattice™ Reconstructive Tissue Matrix, can reduce the surgical complexity and post-operative pain of breast reconstructions with implants by avoiding…
- Trial name
- NCT01853436
- Testing
- Strattice™ Reconstructive Tissue Matrix
- Where
- Italy
- Volunteers
- 36 people
- Sponsor
- LifeCell
Heart Failure
Safety and Efficacy Study of the BioVentrix PliCath HF System
The purpose of this prospective, single-armed, multi-center clinical trial is to further establish the safety and feasibility of using the BioVentrix PliCath HF System for the treatment of left ventricular dysfunction in…
- Trial name
- CONFIGURE-HF (NCT01568164)
- Testing
- PliCath HF System
- Where
- 19 sites in Austria, Czechia and 9 more
- Volunteers
- 120 people
- Sponsor
- BioVentrix
Osteoarthritis, Avascular Necrosis
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities
- Trial name
- NCT03382665
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Zimmer Biomet
Surgery, Gastric Cancer
Clinical Study to Prove Safety and Effectiveness When Applying RUS™ Surgical Navigation
By uploading pre-operative patient information and patient CT data to RUS™, a virtual surgical environment with patient-specific relief prediction models can be provided.
- Trial name
- NCT05039333
- Testing
- RUS(TM) software : surgical navigation
- Where
- South Korea
- Volunteers
- 36 people
- Sponsor
- Hutom Corp
Anterior Cruciate Ligament Reconstruction
Effectiveness of Kneehab in Strengthening the Quadriceps of Patients Post Anterior Cruciate Ligament (ACL) Reconstruction
Prospective, controlled, randomized, single blind study in patients undergoing rehabilitation following anterior cruciate ligament reconstruction. 96 patients were randomly assigned to one of three groups.
- Trial name
- NMES (NCT00737750)
- Testing
- Kneehab, Poli-Stim, Control
- Where
- Germany
- Volunteers
- 131 people
- Sponsor
- Bio-Medical Research, Ltd.
Breast Reconstruction
SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support and Repair in Breast Reconstruction
Prospective, single center, postmarket clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support and repair in breast reconstruction.
- Trial name
- NCT01914653
- Testing
- Silk surgical mesh
- Where
- Israel
- Volunteers
- 17 people
- Sponsor
- Sofregen Medical, Inc.
Peri-implantitis
Reconstruction of Peri-implant Osseous Defects: A Randomized Trial
The purpose of this randomized trial was to compare reconstructive surgery of advanced peri-implant intra-osseous defects with porous titanium granules (PTG/Test) to open flap debridement (OFD/Control) in a non-submerged…
- Trial name
- NCT02406001
- Testing
- Tigran PTG, Surgical intervention
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Tigran Technologies AB
Reconstructive Surgical Procedures
A Retrospective Assessment of OviTex PRS (OviTex)
The objective of this retrospective-prospective, observational study is to evaluate the safety profile overall and within two device types of OviTex PRS in previous pre-pectoral or sub-pectoral implant-based breast…
- Trial name
- PRS (NCT05736848)
- Testing
- OviTex® PRS
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Tela Bio Inc
Tissue Repair, Soft Tissue Reconstruction
Urinary Bladder Matrix (UBM) Registry
The purpose of this registry is to collect real-world information on patients treated with Urinary Bladder Matrix (UBM) products.
- Conditions
- Tissue Repair, Soft Tissue Reconstruction, Wound Management, Pressure Ulcer (PU)
- Trial name
- NCT07805798
- Testing
- Urinary Bladder Matrix (UBM) Products
- Volunteers
- 300 people
- Sponsor
- Integra LifeSciences Corporation
Breast Neoplasms, Carcinoma, Ductal, Breast
Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy
A post-marketing study evaluating the transplantation of autologous fat augmented with Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast deformities post segmental mastectomy or…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Mammaplasty, Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,
- Trial name
- RESTORE-2 (NCT00616135)
- Testing
- ADRC-Enhanced Autologous Fat Transplant
- Where
- 5 sites in Belgium, Italy and 2 more
- Volunteers
- 71 people
- Sponsor
- Cytori Therapeutics
Upper Limb Weakness Due to Central Neurologic Injury, Upper Limb Weakness Due to Peripheral Neurologic Injury
mGain - sEMG-based Gamified Therapy for Improved Upper Limb Rehabilitation
The purpose of this Phase I study is to conduct a pilot clinical trial using a mobile app-connected, wire-free surface electromyography (sEMG) system, called mGain, that provides biofeedback-based therapy in individuals with…
- Conditions
- Upper Limb Weakness Due to Central Neurologic Injury, Upper Limb Weakness Due to Peripheral Neurologic Injury, Upper Limb Weakness Due to Nerve Reconstruction, Upper Limb Weakness Due to Tendon Transfer Surgery
- Trial name
- NCT06023316
- Testing
- mGain system
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Orthocare Innovations, LLC
Aortic Valve Stenosis
PremiCron Suture for Cardiac Valve Repair
The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.
- Trial name
- PremiValve (NCT04096859)
- Where
- 2 sites in Germany, Spain
- Volunteers
- 198 people
- Sponsor
- Aesculap AG