Clinical trials: Abdominal Surgery Complications
Pain, Postoperative
Phase II Clinical Trial to Evaluate the Efficacy and Safety of LPM3480392 Injection for Moderate to Severe Pain After Abdominal Surgery
A randomized, double-blind, placebo/positive drug parallel controlled design was used to evaluate the preliminary efficacy and safety of intravenous infusion of LPM3480392 injection using different dosing regimens in subjects…
- Trial name
- NCT06204120
- Testing
- LPM3480392 Injection, morphine hydrochloride injection
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Luye Pharma Group Ltd.
Postoperative Pain
Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in…
- Trial name
- NCT03237481
- Testing
- HTX-011, Bupivacaine HCl, Luer-lock applicator
- Where
- 24 sites in United States, Belgium
- Volunteers
- 418 people
- Sponsor
- Heron Therapeutics
Abdominal Surgery, Colon Surgery
D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
Subjects who are planned to undergo an abdominal (colon) surgery and who will meet the study entry criteria will be randomly divided into 2 groups: for half D-PLEX will be administered concomitantly with the standard of care…
- Conditions
- Abdominal Surgery, Colon Surgery, Post-Op Infection
- Trial name
- NCT03633123
- Testing
- D-PLEX, Standard of Care (SoC)
- Where
- 8 sites in Israel
- Volunteers
- 202 people
- Sponsor
- PolyPid Ltd.
Laparotomy, Incisional Hernia
Clinical Performance and Safety of Suture-TOOL
The goal of this single arm intervention study is to investigate the safety and performance of a suturing device for closure of the midline incision after open abdominal surgery.
- Conditions
- Laparotomy, Incisional Hernia, Wound Infection, Closure Technique
- Trial name
- NCT05695157
- Testing
- Suture-TOOL
- Where
- Sweden
- Volunteers
- 38 people
- Sponsor
- Suturion AB
Post-Operative Pain
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery
The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after…
- Trial name
- NCT01539642
- Testing
- Sufentanil NanoTab PCA System/15 mcg
- Where
- 12 sites in United States
- Volunteers
- 172 people
- Sponsor
- Talphera, Inc
Pain, Postoperative
An Efficacy and Safety Study to Compare Fentanyl Ionsys and Routine Care With Intravenous (IV) Morphine Patient-controlled Analgesia (PCA) in Participants Who Have Undergone Elective Major Abdominal or Orthopedic Surgery
The purpose of this study is to evaluate the mobilization characteristics, clinical use, safety and Ease of Care (EOC) of a fentanyl Iontophoretic Transdermal Patient Controlled Analgesia (PCA) system (Ionsys) and morphine…
- Trial name
- NCT00766506
- Testing
- Fentanyl IONSYS, Morphine IV PCA
- Where
- 7 sites in United Kingdom
- Volunteers
- 108 people
- Sponsor
- Janssen-Cilag Ltd.
Hernia, Surgical Wound Dehiscence
Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR)
The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive…
- Trial name
- StAR (NCT01083472)
- Testing
- Strattice(TM) Reconstructive Tissue Matrix, Suture/suture with absorbable mesh
- Where
- 29 sites in France, Germany and 4 more
- Volunteers
- 37 people
- Sponsor
- LifeCell
Surgical Site Infection
Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections
The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.
- Trial name
- NCT02255487
- Testing
- IrriSept System, No Intervention - Standard of Care (SoC) only
- Where
- 17 sites in United States
- Volunteers
- 627 people
- Sponsor
- Irrimax Corporation
Peritoneal Carcinomatosis, Ovarian Cancer
A Study of Radspherin® in Patients With Primary Advanced Epithelial Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery
This is a Phase 2, controlled, randomised, parallel assignment, open label, multicentre study to evaluate efficacy and safety of a single intraperitoneal injection of Radspherin® in patients with primary advanced high-grade…
- Trial name
- NCT06504147
- Testing
- Radspherin
- Where
- 10 sites in United States, Belgium and 4 more
- Volunteers
- 114 people
- Sponsor
- Oncoinvent Solutions AS
Analgesia
Extended Delivery of Bupivacaine Study in Herniorrhaphy
This is a phase 4, randomized, open-label study of the efficacy, safety, and pharmacokinetics of bupivacaine administered as liposomal bupivacaine or continuous infusion via elastomeric pump following unilateral open inguinal…
- Trial name
- NCT04102267
- Testing
- Bupivacaine liposome injectable suspension, Bupivacaine HCl without epinephrine via continuous infusion
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Heron Therapeutics
Postsurgical Pain
Efficacy and Safety Study of Ketorolac / Pitofenone / Fenpiverinium for the Treatment of Patients With Pain After Surgical Abdominal and Pelvic Operations
Neospastil (ketorolac tromethamine / pitofenone hydrochloride / fenpiverinium bromide fixed-dose combination) in a form of solution for injections and film-coated tablets has been studied as a treatment for pain after surgical…
- Trial name
- NCT05607641
- Testing
- Ketorolac tromethamine, solution for injection then Neospastil, film-coated tablets, Ketorolac tromethamine, solution for injection then Ketorolac tromethamine, coated tablets, Neospastil, solution for injection then Neospastil, film-coated tablets
- Where
- 14 sites in Ukraine
- Volunteers
- 424 people
- Sponsor
- Darnitsa Pharmaceutical Company
Surgical Site Infection, Colon Surgery
D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)
Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), Compared to a SoC Treated…
- Conditions
- Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection
- Trial name
- D-PLEX312 (NCT04411199)
- Testing
- D-PLEX, Standard of Care (SoC)
- Where
- 58 sites in United States, Bosnia and Herzegovina and 11 more
- Volunteers
- 975 people
- Sponsor
- PolyPid Ltd.
Surgical Site Infections
Study to Assess the Safety & Efficacy of Oral Ciprodiazole Versus Currently Used Ciprofloxacin & Metronidazole
This study aims to assess the safety \& efficacy of Oral Ciprodiazole® versus currently used Ciprofloxacin Tablets \& Metronidazole tablets in pelvi-abdominal infections and following IV antibiotics in post-operative period, for…
- Trial name
- CIPRO-001 (NCT05863832)
- Testing
- Ciprodiazole, Ciprofloxacin Tablets & Metronidazole tablets
- Where
- Egypt
- Volunteers
- 312 people
- Sponsor
- MinaPharm Pharmaceuticals
Postoperative Wound Infection-deep, Post Operative Wound Infection
A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RUT058-60
This is a double-blind, randomized, parallel-group, controlled, multi-center study to evaluate the safety and efficacy of RUT058-60 (Group A) as an intra-cavity lavage compared to sterile saline (Group B) in adult subjects…
- Trial name
- NCT02280395
- Testing
- RUT058-60, Sterile saline for irrigation
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Pulmatrix Inc.
Surgical Wound Infection, Postoperative Wound Infection
Study Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
This is an observational study to evaluate the relative importance of the known risk factors for severe surgical site infections (SSIs) on the development of the more severe SSI cases, and to describe the demographic, clinical…
- Trial name
- EURIDICE (NCT00906074)
- Testing
- Elective or emergency abdominal surgery
- Volunteers
- 180 people
- Sponsor
- Pfizer
Postoperative Pain
Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Analgesia in Abdominal Surgery
This clinical trial is a multiple-center, randomized, double-blind, placebo- and active-controlled parallel-group Phase II/III clinical trial, to evaluate the efficacy and safety of HL-1186 Tablets for Postoperative Analgesia in…
- Trial name
- NCT07709598
- Testing
- HL-1186, Oxycodone-Acetaminophen
- Where
- China
- Volunteers
- 330 people
- Sponsor
- Shanghai Huilun Pharmaceutical Co., Ltd.
Intraabdominal Hypertension, Abdominal Compartment Syndrome
Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry
The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients.
- Conditions
- Intraabdominal Hypertension, Abdominal Compartment Syndrome, Acute Kidney Injury, Cardiovascular Surgery
- Trial name
- NCT04669548
- Testing
- Accuryn Monitoring System
- Where
- 9 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- Potrero Medical
Bladder Carcinoma, Prostate Tumor
Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device
The REMOVE study was an open-label, multicenter validation study on the removal of EpCAM-positive tumor cells from blood collected during tumor surgery using the CATUVAB Kit.
- Conditions
- Bladder Carcinoma, Prostate Tumor, Gallbladder Carcinoma, Endometrial Carcinoma
- Trial name
- REMOVE (NCT06789224)
- Testing
- CATUVAB
- Where
- 6 sites in Germany
- Volunteers
- 136 people
- Sponsor
- Lindis Bloodcare GmbH
Wound Healing and Prevention
Performance, Safety and Efficacy of NPWT Device
Smith \& Nephew are assessing a new investigational single use NPWT system.
- Trial name
- NCT04102865
- Testing
- Negative-Pressure Wound Therapy (NPWT)
- Where
- 8 sites in United Kingdom
- Volunteers
- 90 people
- Sponsor
- Smith & Nephew, Inc.
Gastrointestinal Dysfunction, Malnutrition
Postoperative GI Dysfunction and Nutrition in Malnourished Cancer Surgery Patients
This is a prospective two-center observational cohort study in adult patients undergoing major abdominal and/or pelvic oncologic surgery with pre-existing malnutrition.
- Conditions
- Gastrointestinal Dysfunction, Malnutrition, Delirium - Postoperative, Abdominal Neoplasm
- Trial name
- GIDNUT (NCT07622888)
- Testing
- Serotonin (e.g., serotonin adipinate), Standard Prokinetic Therapy (excluding serotonin)
- Where
- Russia
- Volunteers
- 120 people
- Sponsor
- Arma Ltd.