Clinical trials: Surgery-Complications
Postoperative Pain
Maxigesic® IV Phase 3 Exposure Study
The study aims to determine the tolerability of repeated doses of Maxigesic® IV over an extended period of exposure.
- Trial name
- NCT04005755
- Testing
- Maxigesic® IV
- Where
- 4 sites in United States, New Zealand
- Volunteers
- 232 people
- Sponsor
- AFT Pharmaceuticals, Ltd.
Hernia, Ventral, Hernia, Hiatal
GORE® ENFORM Biomaterial Product Study
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair).
- Conditions
- Hernia, Ventral, Hernia, Hiatal, Hernia, Diaphragmatic, Incisional Hernia
- Trial name
- ENF 18-06 (NCT04718168)
- Testing
- Gore ENFORM Biomaterial (Preperitoneal), Gore ENFORM Biomaterial (Intraperitoneal)
- Where
- 9 sites in United States
- Volunteers
- 245 people
- Sponsor
- W.L.Gore & Associates
Knee Osteoarthritis, Bone; Deformity, Congenital
COREV 2.0 PMCF-Study on Manual and Navigated Revision Knee Patients
The Columbus® Revision endoprosthetic system is bearing the CE-mark. This means that within the scope of this observational study the patient will not be subjected to any additional stressful, study-related medical examinations…
- Conditions
- Knee Osteoarthritis, Bone; Deformity, Congenital, Prosthesis Failure, Prosthesis-Related Infections
- Trial name
- COREV (NCT05113303)
- Testing
- Navigated Revision Total Knee Arthroplasty, Manual Revision Total Knee Arthroplasty
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Aesculap AG
Non-muscle Invasive Bladder Cancer
A First-in-Human Study of alpha1H in Patients With Non-muscle Invasive Bladder Cancer
This study evaluates the tolerability and preliminary anti-tumour effect of alpha1H in adults with non-muscle invasive bladder cancer, who are awaiting transurethral surgery.
- Trial name
- NCT03560479
- Testing
- alpha1H, 7.4 mg/mL, alpha1H, 37 mg/mL, alpha1H, 74 mg/mL
- Where
- Czechia
- Volunteers
- 52 people
- Sponsor
- Hamlet Pharma AB
Blood Loss, Surgical
Observational Cohort Study of TachoSil (TC-018-IN)
The purpose of this study is to collect information, after exposure to TachoSil ®, of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding.
- Trial name
- NCT00285623
- Testing
- Fibrinogen (human) + thrombin (human) (TachoSil)
- Where
- Denmark
- Volunteers
- 3,000 people
- Sponsor
- Nycomed
Surgical Site Infection
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1…
- Trial name
- POLYNOVO-CHD (NCT05966961)
- Testing
- Novosyn® in emergency or elective laparotomy or laparoscopic surgery, Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery
- Where
- 4 sites in Italy, Spain
- Volunteers
- 2,998 people
- Sponsor
- Aesculap AG
Ovarian Cancer
Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)
This Phase 3 study is designed to investigate the safety, diagnostic performance, and clinical usefulness of Gleolan for the real-time detection and visualization of epithelial ovarian cancer tumors during debulking surgery.
- Trial name
- NCT05804370
- Testing
- Gleolan
- Where
- 11 sites in United States
- Volunteers
- 170 people
- Sponsor
- NX Development Corp
Postoperative Pain
Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients
This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8 mg and Q8003 6 mg/4 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute…
- Trial name
- NCT00831051
- Testing
- Q8003, Morphine sulfate, Oxycodone HCl
- Where
- 6 sites in United States
- Volunteers
- 197 people
- Sponsor
- QRxPharma Inc.
Anemia, Blood Loss, Surgical
An Observational Study of Blood Management Techniques in Oncology Surgical Treatment
The purpose of this study is to observe the methods used to manage blood loss in surgical procedures to remove tumors from patients with cancer and to determine if there is a relationship with the need for blood transfusions.
- Conditions
- Anemia, Blood Loss, Surgical, Neoplasms
- Trial name
- NCT00264095
- Testing
- Oncological surgery
- Where
- 11 sites in Netherlands
- Volunteers
- 488 people
- Sponsor
- Janssen-Cilag B.V.
Adnexal Diseases, Uterine Diseases
Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study
This is a prospective, single-center clinical trial. One hundred and fifty patients affected by adnexal and uterine diseases will be recruited to undergo treatment with robotic assisted laparoscopic procedures using the…
- Trial name
- NCT03093675
- Testing
- TELELAP ALF-X Robotic Surgical System
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- SOFAR S.p.A.
Pain, Postoperative
Safety and Efficacy Study of Fentanyl Iontophoretic Transdermal System (ITS) for Management of Moderate to Severe Acute Pain in Participants Who Have Undergone Elective Spine or Orthopedic Surgery
The purpose of this study is to evaluate in daily clinical practice the safety and efficacy of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of moderate (medium level of seriousness) to severe…
- Trial name
- NCT00779038
- Testing
- Fentanyl ITS
- Where
- 3 sites in Belgium
- Volunteers
- 13 people
- Sponsor
- Janssen Cilag N.V./S.A.
Intrauterine Adhesion
PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film
Intrauterine adhesions (IUA) are the major long-term complication of intrauterine procedures and are associated with pelvic pain, menstrual disorders, obstetrical complication and infertility.
- Trial name
- PREG1 (NCT04381728)
- Testing
- Womed Leaf
- Where
- 6 sites in Belgium, France and 1 more
- Volunteers
- 23 people
- Sponsor
- Womed
Surgical Hemorrhage
A Phase III Study of Hemofence for Hemostasis in Patients With Uncontrolled Exudative Hemorrhage During Spinal Or Orthopedic Surgery
This Phase 3 study was conducted to evaluated the efficacy and safety of Hemofence compared with Floseal Hemostatic Matrix in patients undergoing spinal or orthopedic surgery who required hemostasis for exudative bleeding that…
- Trial name
- NCT07824024
- Testing
- Hemofence, Floseal hemostatic matrix
- Where
- 3 sites in South Korea
- Volunteers
- 172 people
- Sponsor
- BMI Korea
Surgery--Complications
Transitional Care Study 3
In this study patients with elective surgery will wear two devices (HealthDot and Elan) after surgery in hospital and after discharge at home for up to 2 weeks (HealthDot) or 3 weeks (Elan).
- Trial name
- TRICA (NCT03923127)
- Testing
- Elan and HealthDot
- Where
- Netherlands
- Volunteers
- 350 people
- Sponsor
- Philips Clinical & Medical Affairs Global
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.
Complications
Femoral Micropuncture or Routine Introducer Study
FEMORIS is a marketing study approved by institutional review boards to compare the rates of complications found when using either the Micropuncture® needle introducer or a standard gauge-18 needle to access the groin blood…
- Trial name
- FEMORIS (NCT01103141)
- Testing
- Micropuncture needle set, Standard gauge-18 needle set
- Where
- 2 sites in United States
- Volunteers
- 143 people
- Sponsor
- Cook Group Incorporated
Ovarian Cancer, Fallopian Tube Cancer
Phase 1 Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer
Immunotherapy is a novel way to treat cancer and does so by targeting the immune system to destroy tumor cells. Many different therapeutic vaccines have been evaluated in phase 1, 2, and even phase 3 trials.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Trial name
- NCT01416038
- Testing
- DPX-Survivac, low dose cyclophosphamide (oral)
- Where
- 7 sites in United States, Canada
- Volunteers
- 19 people
- Sponsor
- ImmunoVaccine Technologies, Inc. (IMV Inc.)
Psychological Stress, Cardiopulmonary Bypass Surgery
CARINAE for Stress Relief in Perioperative Care
Preventing pre-surgical stress can help patients achieve positive outcomes on health and well-being. However, very few patients receive adequate stress relief support prior to a surgical procedure.
- Conditions
- Psychological Stress, Cardiopulmonary Bypass Surgery, Coronary Artery Bypass Surgery, Cardiac Valve Replacement
- Trial name
- CARINAE (NCT05184725)
- Testing
- SaMD CARINAE
- Where
- 5 sites in Italy, Netherlands and 1 more
- Volunteers
- 50 people
- Sponsor
- Adhera Health, Inc.
Rectal Cancer, Anastomotic Leak
Efficacy and Safety of LifeSeal™ Kit for Colorectal Staple Line Sealing
LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over the anastomotic line to prevent bowel content leakage until full physiological function is restored.
- Trial name
- NCT02907385
- Testing
- LifeSeal™ Kit
- Where
- 39 sites in United States, Belgium and 5 more
- Volunteers
- 736 people
- Sponsor
- LifeBond Ltd.
Anastomotic Leaks
Study of Eso-SPONGE for Treating Leaks After Upper Gastrointestinal Surgery
To evaluate the safety and effectiveness of sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE for the treatment of anastomotic leaks in the upper gastrointestinal tract in a prospective multi-center study.
- Trial name
- DRAIN Upper (NCT07711093)
- Testing
- sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Boston Scientific Corporation