Clinical trials: Surgical Outcomes
Cataract
Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses
The purpose of this study is to assess and compare visual outcomes of the AcrySof® IQ ReSTOR® +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.
- Trial name
- NCT01290068
- Testing
- AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, Monofocal IOL
- Volunteers
- 208 people
- Sponsor
- Alcon Research
Prostatic Hyperplasia
Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment
This retrospective study aims to assess the clinical and economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI monotherapy or combination therapy…
- Trial name
- NCT01386983
- Testing
- 5ARI, 5ARI + AB
- Volunteers
- 332 people
- Sponsor
- GlaxoSmithKline
Cataract
Optimizing the Assessment of Refractive Outcomes After Cataract Surgery
The purpose of this study is to evaluate current available assessments (automated vs. manual) with which manifest refraction data and biometric variables are obtained to understand if data from an automated refractor can be…
- Trial name
- NCT02842151
- Testing
- Manifest refraction, ACRYSOF® IQ Monofocal IOL Model SN60WF, Topcon® KR-1W Wave-Front Analyzer
- Volunteers
- 162 people
- Sponsor
- Alcon Research
Complication of Renal Dialysis, End Stage Renal Disease
A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS2 (NCT05425056)
- Testing
- Sirolimus
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 136 people
- Sponsor
- Vascular Therapies, Inc.
Morbid Obesity
Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery
Study objectives: 1. generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery 2.
- Trial name
- OPTIMIZE (NCT01754194)
- Testing
- Gastric Sleeve Resection, Roux-en-Y Gastric Bypass
- Where
- 18 sites in Germany
- Volunteers
- 293 people
- Sponsor
- Medtronic - MITG
Pain
EXPAREL Administered by Infiltration Into the TAP for Prolonged Postsurgical Analgesia in Lower Abdominal Surgeries
The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration…
- Trial name
- TRANSCEND (NCT01919190)
- Testing
- EXPAREL
- Where
- 13 sites in United States
- Volunteers
- 67 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Foot Diseases
Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices
This clinical investigation was led as a post-marketing clinical follow-up study conducted as part of standard care with an additional, non-invasive, non-invasive procedure (Case 4.1) ambispective, multicentre, open-label…
- Trial name
- NCT05672069
- Testing
- Osteosynthesis
- Where
- France
- Volunteers
- 124 people
- Sponsor
- Societe dEtude, de Recherche et de Fabrication
Periodontal Attachment Loss, Periodontal Diseases
Safety and Efficacy of Periodontal Surgery in Supra-alveolar-type Defects With or Without Straumann® Emdogain
The primary objective of this study is to demonstrate that in supra-alveolar-type defects (i.e., defects displaying a predominately horizontal pattern of bone loss), periodontal surgery with the additional use of Straumann®…
- Trial name
- NCT01614925
- Testing
- Emdogain, Periodontal surgery
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Institut Straumann AG
Non-Proliferative Diabetic Retinopathy, Cataract
Nepafenac Once Daily for Macular Edema - Study 2
The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic participants following cataract surgery.
- Trial name
- NCT01872611
- Testing
- Nepafenac Ophthalmic Suspension, 0.3%, Vehicle, Prednisolone acetate
- Volunteers
- 819 people
- Sponsor
- Alcon Research
Rectal Cancer, Rectosigmoid Cancer
A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
This is a randomized, controlled, parallel, multicenter study to determine the difference in post-operative anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using…
- Trial name
- PILLAR III (NCT02205307)
- Testing
- PINPOINT, SPY Elite
- Where
- 24 sites in United States
- Volunteers
- 347 people
- Sponsor
- Novadaq Technologies ULC, now a part of Stryker
Complication of Renal Dialysis, End Stage Renal Disease
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS (NCT02513303)
- Testing
- Sirolimus, AV Fistula Surgery, Sirolimus-eluting Collagen Implant (SeCI)
- Where
- 4 sites in United States
- Volunteers
- 269 people
- Sponsor
- Vascular Therapies, Inc.
Atrial Fibrillation, Atrial Flutter
FREEZE-AFIB Post-Market Study
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device.
- Trial name
- NCT05089877
- Testing
- Surgical Ablation
- Where
- 6 sites in United States
- Volunteers
- 39 people
- Sponsor
- AtriCure, Inc.
Bloodloss, Surgical Procedures, Operative
A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume
The purpose of this study is to assess the efficacy and identify the optimal dose(s) of ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery including the use of cardio pulmonary bypass.
- Trial name
- CONSERV-1 (NCT00816023)
- Testing
- ecallantide
- Where
- 29 sites in United States, Canada
- Volunteers
- 276 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Obesity
Metabolic Factors of Outcomes From Gastric Bypass Surgery
The objective of this study is to determine whether the metabolic, endocrine and energetic response to short term caloric restriction are factors in weight loss in subjects having gastric bypass (GB) surgery.
- Trial name
- Cassini (NCT01347840)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Ethicon Endo-Surgery
Cataract Surgery
A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device
The purpose of this research study is to evaluate the clinical outcomes of current phacoemulsification approaches to cataract extraction involving high-frequency thermogenic energy versus the use of the MICOR System device using…
- Trial name
- NCT05729477
- Testing
- miCOR System, Phaco Subject Cohort
- Where
- 6 sites in United States
- Volunteers
- 402 people, healthy volunteers welcome
- Sponsor
- Carl Zeiss Meditec, Inc.
Nonmelanoma Skin Cancer
Comparison of eBX and Mohs Surgery for Treatment of Early-stage Non-melanoma Skin Cancer a Matched Pair Cohort Study.
This is a retrospective-prospective study design. Patients who completed treatment approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be identified and any existing data in the patient's record…
- Trial name
- NCT03024866
- Testing
- Electronic Brachytherapy
- Where
- 4 sites in United States
- Volunteers
- 369 people
- Sponsor
- Xoft, Inc.
Obstructive Defecation Syndrome, Chronic Constipation
Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)
The primary purpose of this study is to determine how effective and how durable STARR (stapled transanal rectal resection) surgery is in relieving symptoms of intractable constipation associated with obstructive defecation…
- Conditions
- Obstructive Defecation Syndrome, Chronic Constipation, Rectocele, Intussusception
- Trial name
- NCT00256984
- Testing
- Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler
- Where
- 7 sites in United States
- Volunteers
- 75 people
- Sponsor
- Ethicon Endo-Surgery
Surgical Wound
VASCADE ANTEGRADE-PVD Post-Market Registry
The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional…
- Trial name
- NCT02948257
- Testing
- Cardiva Medical VASCADE VCS
- Where
- 5 sites in United States
- Volunteers
- 52 people
- Sponsor
- Cardiva Medical, Inc.
Rhinosinusitis
Healthcare Utilization and Outcomes of FinESS Treatment in the Office
A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office.
- Trial name
- RELIEF (NCT00986830)
- Testing
- FinESS Sinus Treatment
- Where
- 13 sites in United States
- Volunteers
- 74 people
- Sponsor
- Entellus Medical, Inc.
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Elite Valve System
The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a…
- Trial name
- MISSION (NCT02907463)
- Where
- 23 sites in Austria, Denmark and 7 more
- Volunteers
- 280 people
- Sponsor
- Edwards Lifesciences