Clinical trials: Image Reconstruction
Breast Cancer
Patient Controlled Tissue Expansion for Breast Reconstruction
This study is designed to compare the performance and safety of the AirXpander tissue expander to standard saline expanders in patients undergoing two-stage breast reconstruction following mastectomy.
- Trial name
- XPAND (NCT01425268)
- Testing
- AeroForm Tissue Expansion, Saline Tissue Expansion
- Where
- 17 sites in United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- AirXpanders, Inc.
Breast Reconstruction
The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction
Breast reconstruction after mastectomy has been shown to provide psychosocial benefits to breast cancer patients and is considered an integral part of breast cancer treatment.
- Trial name
- REaCT-ADM (NCT03064893)
- Testing
- Alloderm, Dermacell
- Where
- Canada
- Volunteers
- 62 people
- Sponsor
- Ottawa Hospital Research Institute
Intracranial Aneurysm
Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device
The purpose of this study is to demonstrate effectiveness and safety of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System.
- Trial name
- NCT02532517
- Testing
- CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System
- Where
- 11 sites in United States
- Volunteers
- 45 people
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Werewolf Flow 50 During ACL Reconstruction
The aim of this study is to compare the outcomes, ease of use, and cost of the Werewolf FLOW50 device to the institutional standard of care which is does not include the use of electrocautery devices during anterior cruciate…
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Arthrofibrosis of Knee
- Trial name
- NCT04998656
- Testing
- Werewolf FLOW 50, Control
- Where
- 3 sites in United States
- Volunteers
- 182 people
- Sponsor
- University of Colorado, Denver
Trauma, Vascular System Injury
Humacyte Acellular Tissue Engineered Vessel (ATEV) in Patients With Vascular Trauma
This study evaluates the use of the Acellular Tissue Engineered Vessel (ATEV) in adults with vascular trauma below the neck who are undergoing vascular reconstructive surgery.
- Trial name
- NCT03005418
- Testing
- Acellular Tissue Engineered Vessel (ATEV)
- Where
- 29 sites in United States, Israel
- Volunteers
- 72 people
- Sponsor
- Humacyte, Inc.
Breast Cancer
Impact of Topical Tranexamic Acid in Breast Reconstruction
Improvement in bleeding and bruising has been described by using both intravenous and topical off-label applications of Tranexamic Acid (TXA) in many surgical fields.
- Trial name
- NCT05807074
- Testing
- Tranexamic Acid, Saline
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- University of California, San Francisco
Coronary Artery Disease
Diagnostic Accuracy of On-line Quantitative Flow Ratio (QFR). FAVOR II Europe-Japan
Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is assessed by calculation of the pressure in the vessel based on two angiographic projections.
- Trial name
- FAVOR II EJ (NCT02959814)
- Testing
- QFR (observational)
- Where
- 10 sites in Denmark, France and 5 more
- Volunteers
- 329 people
- Sponsor
- Aarhus University Hospital Skejby
Anterior Cruciate Ligament Injury
Functional Resistance Training to Improve Knee Function After ACL Reconstruction
The purpose of this study is to examine if thigh muscle weakness and the lack of muscle activation that accompanies ACL injury and reconstruction can be improved with functional resistance training.
- Trial name
- NCT03282565
- Testing
- Functional Resistance Training with Brace, Control, Functional Resistance Training with Elastic Band
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Michigan
Aortic Insufficiency
HAART 200 Aortic Valve Annuloplasty Trial
The HAART 200 "Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction" Trial is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART 200 bicuspid annuloplasty ring when…
- Trial name
- NCT02071849
- Testing
- HAART 200 Aortic Valve Annuloplasty Device
- Where
- 4 sites in Germany
- Volunteers
- 20 people
- Sponsor
- Biostable Science & Engineering
Post Operative Pain
RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain
This randomized controlled trial will evaluate the effects of perioperative intravenous (IV) acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing vaginal reconstructive surgery.
- Trial name
- NCT02043704
- Testing
- IV Acetaminophen
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- TriHealth Inc.
Rupture of Anterior Cruciate Ligament
Analgesic Benefits of Genicular Nerve Blocks of the Posterior Knee for Patients Undergoing ACL Reconstruction
Outpatients scheduled to have ACL surgery typically receive a femoral nerve block to provide analgesia for the front of the knee. Postoperatively, these patients will often report pain in the back of the knee.
- Trial name
- NCT02008617
- Testing
- Bupivacaine, Preservative free normal saline
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Northwestern University
Cruciate Ligament Reconstruction, Knee
Safety and Effectiveness of BIOSURE RG in Cruciate Ligaments Reconstruction in Chinese
The objective of this study is to compare the safety and effectiveness of Biosure Regenesorb Interference Screw versus BIOSURE HA Interference Screw (control device) in patients requiring reconstruction of cruciate ligaments of…
- Trial name
- NCT04012567
- Testing
- Investigational device: Biosure Regenesorb Interference Screw, Control device: BIOSURE HA Interference Screw
- Where
- 4 sites in China
- Volunteers
- 140 people
- Sponsor
- Smith & Nephew, Inc.
Diabetes Mellitus Type 2 in Nonobese, Gastric Cancer
Safety and Efficacy of Long Limb Roux-en Y Reconstruction
We grafted the concept of metabolic surgery (long limb Roux-en Y reconstruction) into gastric cancer surgery. This study aimed to investigate the safety and efficacy of long limb Roux-en Y reconstruction after gastrectomy in…
- Trial name
- LoLiRoRe (NCT01373346)
- Testing
- Long limb Roux-en Y reconstruction
- Where
- South Korea
- Volunteers
- 15 people
- Sponsor
- Gangnam Severance Hospital
Breast Cancer
Breast Capsular Contracture Following Post-Mastectomy Reconstruction in Women Treated With the Leukotriene Inhibitor Zafirlukast: A Phase II Trial
A 2 arm, 90 patient (45 per cohort) trial in patients with breast cancer who will be undergoing mastectomy with immediate tissue-expander reconstruction to determine whether treatment with zafirlukast (20mg PO BID) can reduce or…
- Trial name
- NCT02950480
- Testing
- zafirlukast, Standard of Care (no intervention)
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of California, San Francisco
Breast Cancer
Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach
Although clinical decision tools (CDTs) exist for a variety of treatments, CDTs designed to support personalized breast reconstruction decisions, particularly about type and timing of reconstruction, are lacking.
- Trial name
- NCT03346161
- Testing
- Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction", Decision tool, Usual Care Group - Outcome Measures
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Washington University School of Medicine