Clinical trials: Peri-operative
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver Transplantation
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C virus (HCV)-infected adults who are undergoing…
- Trial name
- NCT02728206
- Testing
- SOF/VEL
- Where
- New Zealand
- Volunteers
- 9 people
- Sponsor
- Gilead Sciences
Otitis Media With Effusion
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
- Trial name
- NCT01949155
- Testing
- OTO-201
- Where
- United States
- Volunteers
- 266 people
- Sponsor
- Otonomy, Inc.
Bilateral Middle Ear Effusion
Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement.
- Trial name
- NCT02350998
- Testing
- OTO-201
- Where
- 5 sites in United States
- Volunteers
- 33 people
- Sponsor
- Otonomy, Inc.
Ileus, Post-Operative Adhesions
A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection
The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of post-operative ileus and intra-abdominal adhesions in subjects undergoing elective bowel…
- Trial name
- PROFILE (NCT02836470)
- Testing
- LB1148
- Where
- 28 sites in United States
- Volunteers
- 112 people
- Sponsor
- Palisade Bio
Hypothermia, Complications
Impact of Expanded Peri Operative Warming
The purpose of this proposed study is to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery.
- Trial name
- NCT01649596
- Testing
- Warming Gown, Standard of care warming
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Ascension Health
Cholecystectomy
Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy
A multi-center retrospective chart review of short-term outcomes associated with robotic-assisted cholecystectomies performed during regular hours and after-hours.
- Trial name
- SPARC (NCT04551820)
- Testing
- Regular Hours, After Hours, Robotic-assisted Cholecystectomy
- Where
- United States
- Volunteers
- 505 people
- Sponsor
- Intuitive Surgical
Spinal Surgery
Comparison Between Return and Wastage of Your Own Blood, Collected During Spinal Surgery, for Verification of Safety When Returning Blood
The study is an open, randomized, controlled, single-centre study including a total of 42 evaluable subjects scheduled for spinal surgery with an approximate expected bleeding of 800-1500 ml.
- Trial name
- NCT01251042
- Testing
- Sangvia
- Where
- Denmark
- Volunteers
- 51 people
- Sponsor
- Wellspect HealthCare
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting
The primary objective of this study is to evaluate the antiviral efficacy of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver transplantation and through 4 weeks…
- Trial name
- NCT02350569
- Testing
- LDV/SOF
- Where
- 6 sites in United States
- Volunteers
- 17 people
- Sponsor
- Gilead Sciences
Postoperative Cardiac Complication, Heart Failure
More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges
This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and…
- Conditions
- Postoperative Cardiac Complication, Heart Failure, Left Ventricular Cardiac Dysfunction, Inappropriate Phrenic Nerve Stimulation
- Trial name
- MORE-CRT (NCT01510652)
- Testing
- BiP Group, Quad Group
- Where
- 64 sites in Belgium, Canada and 11 more
- Volunteers
- 1,078 people
- Sponsor
- Abbott Medical Devices
Proven or Suspected Gram-negative Bacterial Infection, Peri-operative Prophylaxis
Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis (MK-7625A-010)
The purpose of this study was to assess the pharmacokinetics, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam (MK-7625A) in pediatric participants.
- Trial name
- NCT02266706
- Testing
- Ceftolozane/Tazobactam 1000/500 mg, Ceftolozane/Tazobactam 30/15 mg/kg, Ceftolozane/Tazobactam 20/10 mg/kg
- Volunteers
- 43 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Ovarian Cancer
Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer
This study is being done to: test the safety of OTL38 see if OTL38 helps light up the cancer when viewed with the special camera system test the safety of the special camera system for use along with OTL38 during surgery
- Trial name
- NCT02317705
- Testing
- OTL38, Near infrared camera imaging system, Laparotomy
- Where
- 4 sites in United States
- Volunteers
- 48 people
- Sponsor
- On Target Laboratories, LLC
Otitis Media With Effusion
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
- Trial name
- NCT01949142
- Testing
- OTO-201
- Where
- United States
- Volunteers
- 266 people
- Sponsor
- Otonomy, Inc.
Total Knee Replacement
Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement
The study is a prospective, randomized, double-blind sham study of TKA patients who receive a standard peri-operative treatment program plus Kneehab XP versus a standard peri-operative treatment program plus a sham device.
- Trial name
- NCT01548040
- Testing
- Kneehab XP, Quadriceps TENS
- Where
- United States
- Volunteers
- 111 people
- Sponsor
- Theragen Inc.
Bleeding Disorder, Hypofibrinogenemia; Acquired
Adjusted Fibrinogen Replacement Strategy
The main purpose of this study was to demonstrate the efficacy and safety of intraoperative use of fibrinogen concentrate BT524, as a complementary therapy for the management of uncontrolled severe hemorrhage in acquired…
- Trial name
- AdFIrst (NCT03444324)
- Testing
- BT524, FFP/Cryo
- Where
- 19 sites in Belgium, Czechia and 5 more
- Volunteers
- 222 people
- Sponsor
- Biotest
Surgery
Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical Outcomes
The study evaluates the use of noninvasive hemoglobin with In Vivo feature and PVi monitoring using pulse-oximetry based technologies and their effect on the management of transfusion and infusion decisions and clinical outcomes…
- Trial name
- NCT02986789
- Testing
- In vivo SpHb and PVi Monitoring
- Volunteers
- 43 people
- Sponsor
- Masimo Corporation
Pulmonary Disease, Chronic Obstructive
Ipratropium Bromide in Peri-Operative COPD
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-centre trial.The trial aims to evaluate efficacy of nebulized ipratropium bromide in Chinese peri-operative patients with COPD under general…
- Trial name
- NCT01943552
- Testing
- ipratropium bromide
- Where
- 9 sites in China
- Volunteers
- 192 people
- Sponsor
- Boehringer Ingelheim
Hearing Impairment, Sensorineural
Cochlear Response Telemetry and Hearing Preservation
The main purpose of this study is to monitor the response from the cochlea as the electrode is inserted during the operation to receive a cochlear implant.
- Trial name
- CREST (NCT03134989)
- Testing
- Cochlear implant
- Where
- Argentina
- Volunteers
- 80 people
- Sponsor
- Cochlear
Rectal Cancer, Colon Cancer
Perfusion Assessment in Laparoscopic Left Anterior Resection
The purpose of this study is to demonstrate that NIR fluorescence angiography using the PINPOINT Endoscopic Fluorescence Imaging System ("PINPOINT System" or "PINPOINT") can assess viability of colon tissue during laparoscopic…
- Conditions
- Rectal Cancer, Colon Cancer, Crohn's Disease, Polyp
- Trial name
- PILLAR II (NCT01560377)
- Testing
- PINPOINT Endoscopic Fluorescence Imaging System
- Where
- 11 sites in United States
- Volunteers
- 147 people
- Sponsor
- Novadaq Technologies ULC, now a part of Stryker
Lung Injury, Acute and Respiratory Distress Syndrome, Adult
Study of GSK2862277 in Subjects Undergoing Oesophagectomy Surgery
Lung injury in patients undergoing oesophagectomy may occur during surgery (peri-operatively) as a result of One Lung Ventilation (OLV) and/or during the immediate post-operative period when patients receive intensive care.
- Trial name
- NCT02221037
- Testing
- GSK2862277
- Where
- 6 sites in United Kingdom
- Volunteers
- 35 people
- Sponsor
- GlaxoSmithKline
Ovarian Cancer
OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval…
- Trial name
- NCT03180307
- Testing
- OTL38, near infrared camera imaging system, laparotomy
- Where
- 11 sites in United States, Netherlands
- Volunteers
- 140 people
- Sponsor
- On Target Laboratories, LLC