Clinical trials: Leakage
Stoma Site Leakage
A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
An investigation of non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.
- Trial name
- NCT04544566
- Testing
- Test product A, Test product B, Comparator
- Where
- Denmark
- Volunteers
- 12 people
- Sponsor
- Coloplast A/S
Injection Site Reaction
A Study Comparing the Local Tolerability of Two Subcutaneous Heparins in Healthy Volunteers.
A Phase IV, Randomised, Double-blind, Single-centre clinical trial in healthy male and female participants aged 18 to 55, that was designed to assess and compare the pain intensity at an injection site as well as the duration of…
- Trial name
- NCT03841396
- Testing
- Sodium chloride
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Aspen Global Incorporated
Anastomotic Leak
Economic Evaluation of Stream™ Platform
This Economic Evaluation study is a multi-center, two-arm, non-randomized, interventional trial. The purpose of this study is to evaluate the economic and patient outcomes of using the Stream™ Platform for early detection of…
- Trial name
- CostAL (NCT05994625)
- Testing
- Stream™ Platform, Stream™ Platform with Risk Score Omitted
- Where
- 2 sites in Canada
- Volunteers
- 215 people
- Sponsor
- FluidAI Medical
Cerebrospinal Fluid Leakage
Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective Craniotomy
This is a prospective study to evaluate the performance and safety of a new medical device used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.
- Trial name
- NCT01295619
- Testing
- I-020805
- Where
- 4 sites in Germany, Hungary
- Volunteers
- 41 people
- Sponsor
- Kuros Biosurgery AG
HIV Infections
A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV
This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables.
- Trial name
- NCT06970223
- Testing
- Cabotegravir long-acting, Lenacapavir long-acting
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Anastomotic Leaks, Hartmanns Stump Leakage
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
This study is intended to evaluate the safety and effectiveness of Sponge-based Endoscopic Vacuum Therapy (EVT) using Endo-SPONGE for the treatment of Anastomotic Leaks (AL) or Hartmann's stump leakages following colorectal…
- Trial name
- DRAIN Lower (NCT07035431)
- Testing
- Endo-SPONGE
- Where
- 10 sites in United States
- Volunteers
- 66 people
- Sponsor
- Boston Scientific Corporation
Leakage
A Clinical Investigation of New Ostomy Appliances
This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks.
- Trial name
- NCT01523756
- Testing
- test product 1: new ostomy base plate with Coloplast as manufacturer, test product 2: new ostomy base plate with Coloplast as manufacturer
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Coloplast A/S
Injection Site Reaction
Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products
The objective of this study is to identify and assess in vivo tissue responses after injection with various biostimulatory products at various timepoints.
- Trial name
- NCT06093815
- Testing
- Injection
- Where
- Spain
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Merz North America, Inc.
Leakage After Esophagectomy, Leakage After Gastrectomy
Eso-Sponge Registry
This international, prospective and multicenter registry was designed to collect clinical evidence for the endoscopic vacuum treatment using Eso-SPONGE® for anastomotic leakage after esophageal resection or iatrogenic or…
- Conditions
- Leakage After Esophagectomy, Leakage After Gastrectomy, Perforation of the Esophagus
- Trial name
- NCT02662777
- Testing
- Eso-SPONGE® vacuum treatment
- Where
- 17 sites in Germany
- Volunteers
- 108 people
- Sponsor
- Aesculap AG
Pancreatectomy, Hepatic Resection
Safety and Performance of a Synthetic Tissue Sealant in Reducing Fluid Leakage in Hepatobiliary and Pancreatic Surgery
Polyganics BV (Groningen, The Netherlands), in close collaboration with University Hospital-Eppendorf (UKE) Hamburg, has developed the Sealing Device for use in hepato-pancreato-bilary (HPB) surgery to reduce leakage of fluids…
- Trial name
- SHIELDS (NCT04024956)
- Testing
- Sealing Device
- Where
- 2 sites in Germany
- Volunteers
- 80 people
- Sponsor
- Polyganics BV
Type 2 Diabetes Mellitus
Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715
10 healthy volunteers will be enrolled to each receive two subcutaneous injections of ISIS 113715 in the abdomen on Study Day 1. Each subject will receive their two injections within a 5-minute period.
- Trial name
- NCT00365781
- Testing
- ISIS 113715
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Ionis Pharmaceuticals, Inc.
Pneumothorax
Evaluation of the Feasibility, Safety, and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax
Study Objective: To evaluate the feasibility and safety of the disposable endobronchial silicon spigots for treating refractory pneumothorax and to preliminarily assess its efficacy, providing domestic experience for the…
- Trial name
- NCT06515015
- Testing
- Endobronchial Silicon Spigots
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Hangzhou Broncus Medical Co., Ltd.
Anthracycline Extravasation
Efficacy of TopotectTM (Dexrazoxane) for Accidental Extravasation of Anthracyclines
The purpose of this study is to avoid surgical intervention following extravasation of anthracycline chemotherapy out of a vessel into the surrounding tissues.
- Trial name
- NCT00548561
- Testing
- Dexrazoxane
- Where
- 9 sites in Denmark
- Volunteers
- 23 people
- Sponsor
- Valerio Therapeutics
Drug Extravasation, Kidney Cancer
Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. Biomed 101 may protect normal cells from the side effects of interleukin-2.
- Trial name
- NCT00004890
- Testing
- aldesleukin, Biomed 101
- Where
- United States
- Sponsor
- BioMedicines
Fecal Incontinence, Bowel Dysfunction
LIBERATE - PRO: Eclipse™ System Registry
A prospective, open label post market registry to collect Patient Reported Outcomes in an online data capture registry, maintained by Pelvalon, of women with fecal incontinence exiting the LIBERATE study (NCT02428595) continuing…
- Conditions
- Fecal Incontinence, Bowel Dysfunction, Bowel Incontinence, Accidental Bowel Leakage
- Trial name
- LIBERATEPRO (NCT03028636)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Pelvalon, Inc.
Stoma Ileostomy
Investigation of a Supporting Ostomy Product Intended for Leakage Detection
People with intestinal stomas (especially an ileostomy) can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively.
- Trial name
- NCT04894084
- Testing
- CP321
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Coloplast A/S
Infiltration of Peripheral IV Therapy
ivWatch Model 400: Device Validation for Infiltrated Tissues
A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV therapy.
- Trial name
- NCT02123745
- Testing
- The ivWatch Model 400
- Where
- United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- ivWatch, LLC
Anastomotic Leak, Colon Cancer
Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy
The primary aim of the study is to show that the ileo-colic anastomosis leakage rate until the first 30 days after surgery using MonoPlus® suture material for anastomosis construction after right hemicolectomy is not inferior to…
- Conditions
- Anastomotic Leak, Colon Cancer, Right Hemicolectomy
- Trial name
- LICOSARH (NCT07132970)
- Testing
- Monoplus Suture Material
- Where
- 4 sites in Germany
- Volunteers
- 249 people
- Sponsor
- Aesculap AG
Urinary Incontinence
A Clinical Trial to Evaluate Leakage Performance in a Hybrid Absorbing Incontinence Product
The study is prospective, sequential, single group, and interventional but not invasive. The primary objective is to evaluate the leakage performance of the investigational medical devices (absorbing hygiene products, AHPs)…
- Trial name
- NCT06091111
- Testing
- THD, THN
- Where
- United Kingdom
- Volunteers
- 42 people
- Sponsor
- Essity Hygiene and Health AB
Spinal Dural Defect, Cerebrospinal Fluid Leakage
Dural Medical Adhesive for Watertight Sealing in Dural Repair
This is a prospective, multicenter, single-blind, randomized controlled superiority clinical trial of dural medical adhesive for watertight sealing after primary spinal dural repair to prevent cerebrospinal fluid (CSF) leakage.
- Conditions
- Spinal Dural Defect, Cerebrospinal Fluid Leakage, Spinal Neurosurgery
- Trial name
- NCT07754344
- Testing
- Dural medical adhesive, Standard dural reinforcement surgery
- Where
- 6 sites in China
- Volunteers
- 141 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.