Clinical trials: Reconstructive Surgery
Breast Reconstruction, Breast Reconstruction Following Mastectomy
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive being the primary indications. In order to confidently state safety and due to strict regulation on medical devices it is important to…
- Conditions
- Breast Reconstruction, Breast Reconstruction Following Mastectomy, Breast Revision, Breast Augmentation
- Trial name
- PERLE10PMCF (NCT06013514)
- Testing
- PERLE Sterile Smooth Opaque gel filled mammary implants
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- GCA (Eurosilicone)
Breast Augmentation, Breast Reconstruction
A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants
The goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical…
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision-Augmentation, Breast Reconstruction With Silicone Implants
- Trial name
- NCT07679594
- Testing
- Breast augmentation surgery, Breast reconstruction surgery
- Where
- 2 sites in France, Spain
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- GCA (Eurosilicone)
Breast Augmentation, Breast Reconstruction
Evaluation of the Safety and Performance of ESTYME® MATRIX Round and Anatomical Breast Implants - EMMIE Study
The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction.
- Trial name
- EMMIE (NCT03386682)
- Testing
- ESTYME® MATRIX Breast Implants
- Where
- 8 sites in France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Symatese Aesthetics
Anterior Cruciate Ligament Reconstruction
Effectiveness of Kneehab in Strengthening Quadriceps in Rehabilitation 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 (NCT00738010)
- Testing
- Kneehab, Poli-Stim, Control
- Where
- Germany
- Volunteers
- 131 people
- Sponsor
- Bio-Medical Research, Ltd.
Anterior Cruciate Ligament Rupture
Tolerance, Efficacy, revAlidation, Myostim
Evaluation of efficacy and tolerance of a food supplement (MYOSTIM®) versus a placebo in postoperative revalidation of patients after reconstructive surgery of anterior cruciate ligament.
- Trial name
- NCT04684771
- Testing
- MYOSTIM®
- Where
- 2 sites in Belgium
- Volunteers
- 35 people
- Sponsor
- Alternativa International S.A
Congestive Heart Failure, Ischemic Cardiomyopathy
Study Tests Whether a Standardized LVR Performed With the Blue Egg Device Improves Cardiopulmonary Exercise Capacity
The purpose of the present prospective, randomized study is to investigate the clinical effectiveness of standardized left ventricular reconstruction surgery (LVR).
- Conditions
- Congestive Heart Failure, Ischemic Cardiomyopathy, Coronary Artery Disease, Myocardial Diseases
- Trial name
- NCT00326690
- Testing
- Blue Egg Device
- Where
- 10 sites in United States, Germany
- Volunteers
- healthy volunteers welcome
- Sponsor
- BioVentrix
Breast Reconstruction
Effectiveness and Safety of OviTex® PRS in Breast Reconstruction
The purpose of this study is to evaluate the safety and effectiveness of OviTex PRS in subjects undergoing implant-based breast reconstruction.
- Trial name
- RESTORE (NCT07135596)
- Testing
- OviTex PRS
- Where
- 3 sites in United States
- Volunteers
- 235 people
- Sponsor
- Tela Bio Inc
Perfusion; Complications
Evaluation of Tissue Oxygen Levels During Breast Reconstruction With a New Surgical Device
This study is designed to evaluate the information provided to the clinicians by the surgical imaging device. It is also to gain insight on the user interface and how "user friendly" it is to the clinician.
- Trial name
- Presygen™ (NCT03715270)
- Testing
- Image surgical area
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Christie Medical Holdings, Inc.
Ruptured Anterior Cruciate Ligaments
Safety and Efficacy Study of the Z-Lig Medical Device Compared to Allograft
The purpose of this Trial is to demonstrate the safety and efficacy of the Investigational Device for the treatment of ruptured Anterior Cruciate Ligament (ACL) of the knee compared to Allograft.
- Trial name
- Z-Lig (NCT01245400)
- Testing
- Z-Lig, allograft
- Where
- 6 sites in Belgium, Denmark and 4 more
- Volunteers
- 60 people
- Sponsor
- Aperion Biologics, Inc.
Breast Reconstruction
DuraSorb® in Prosthetic Breast Reconstruction
This study compares outcomes of prospective mesh-based breast reconstructions to historical control breast reconstructions with no mesh.
- Trial name
- NCT04646057
- Testing
- DuraSorb®
- Where
- 7 sites in United States
- Volunteers
- 168 people
- Sponsor
- Surgical Innovation Associates, Inc.
Hernia, Abdominal, Abdominal Injuries
ENHANCE: A Prospective EvaluatioN of Permacol™ in tHe Repair of Complex AbdomiNal Wall CasEs
The objective of this prospective study is to evaluate short-term, mid-term, and long-term clinical outcomes associated with the use of Permacol™ Biological Implant in the treatment of complex abdominal wall defects
- Trial name
- ENHANCE (NCT01268514)
- Where
- 12 sites in Belgium, Germany and 3 more
- Volunteers
- 115 people
- Sponsor
- Medtronic - MITG
Breast Implants
Study of the Safety and Effectiveness of Motiva Implants®
This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.
- Trial name
- NCT03579901
- Testing
- Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
- Where
- 29 sites in United States, Germany and 1 more
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Motiva USA LLC
Cancer
App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic Toxicity in Cancer Patients - Aim 3
The goal of this observational study is to develop a mobile app for cancer patients undergoing treatments. In Aim 3, patients will rate the quality of the app using the Mobile App Rating Scale (MARS) and their satisfaction with…
- Trial name
- NCT06322992
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Daynamica, Inc.
Pain, Postoperative
A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy for Anterior Cruciate Ligament (ACL) Reconstruction
To demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac sodium delayed release 75 mg BID in analgesic…
- Trial name
- NCT00650598
- Testing
- valdecoxib, diclofenac
- Where
- 25 sites in Australia, Hong Kong and 7 more
- Volunteers
- 328 people
- Sponsor
- Pfizer
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
Anterior Cruciate Ligament Rupture
Obtain Safety and Effectiveness of CT-ACL001, a Regenerative Ligament Using Biological Tissue, in ACLR
A randomized, multicenter study comparing the safety and efficacy of CT-ACL001, a regenerative ligament, with standard treatment in anterior cruciate ligament reconstruction
- Trial name
- NCT07129694
- Testing
- Anterior cruciate ligament reconstruction
- Where
- 6 sites in Japan
- Volunteers
- 64 people
- Sponsor
- CoreTissue BioEngineering Inc.
Breast Tissue Accessory, Breast Cancer
Motiva Flora Tissue Expander PMCF
The Motiva Flora® Tissue Expander clinical study (hereafter Motiva Flora® TE study) is a 6-month, open-label, prospective, multicentre post-marketing follow-up study designed to confirm the Safety and Effectiveness/Performance of…
- Trial name
- NCT05447988
- Testing
- Breast Tissue Expander
- Where
- 5 sites in Chile, Costa Rica and 2 more
- Volunteers
- 136 people
- Sponsor
- Establishment Labs
Breast Cancer Female, Breast Reconstruction
Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction
The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been…
- Trial name
- ADM (NCT06555614)
- Testing
- Acellular Dermal Matrix(ADM)
- Where
- South Korea
- Volunteers
- 120 people
- Sponsor
- DOF Inc.
Cartilage Disease
Observational Study With NOVOCART® Inject in the Reconstruction of the Hip Joint With Full Thickness Cartilage Defects
Non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full thickness cartilage defects in the hip.
- Trial name
- HIP-ACTION (NCT02179346)
- Where
- 3 sites in Germany
- Volunteers
- 21 people
- Sponsor
- Tetec AG
Flap Ischemia, Hypoxia
Spectroscopic Assessment of Tissue Oxygenation Changes in Plastic Surgical Flap Reconstructions
This study is a single-center, observational study designed to collect tissue spectrometric data.
- Trial name
- NCT07786610
- Volunteers
- 30 people
- Sponsor
- Spectrocor