Clinical trials: Medical Device Complication
Hemorrhagic Complications, Hematoma
Safety and Efficiency of the PacePress to Prevent Hemorrhagic Complications in Patients Undergoing CIED Implantation.
PacePress medical device, by ensuring constant compression force and the ability to optimize it in the pocket area prevents/significantly reduces the risk of hemorrhagic complications, including but not limited to the operation…
- Conditions
- Hemorrhagic Complications, Hematoma, Hemorrhage, Pathologic Processes
- Trial name
- PacePress (NCT05292326)
- Testing
- PacePress, standard compression band
- Where
- 7 sites in Poland
- Volunteers
- 122 people
- Sponsor
- Medinice S.A.
Perfusion; Complications, Wound; Foot
Avazzia-University of Texas Southwestern Medical Center-Tennant Biomodulator® PRO Perfusion Study
This study is an open label trial designed to test the effectiveness of the Tennant Biomodulator® PRO electrical stimulation device (Avazzia), which uses BEST™ (Bio-Electric Stimulation Technology), on hospital in-patients to…
- Trial name
- NCT03843307
- Testing
- Avazzia Tennant Biomodulator® PRO
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Avazzia, Inc
Kidney Stones, Urolithiasis
DISON I - Directly Integrated Suction and Optics System for the Treatment of Nephrolithiasis
A single-arm, multicenter, international, prospective interventional study designed to evaluate the safety and performance of an investigational device during retrograde intrarenal surgery for the treatment of renal calculi.
- Conditions
- Kidney Stones, Urolithiasis, Nephrolithiasis
- Trial name
- DISON I (NCT07712861)
- Testing
- RIRS with Investigational Device
- Where
- 5 sites in Argentina, Canada and 3 more
- Volunteers
- 75 people
- Sponsor
- Ventaris Surgical Incorporated
Bacterial Vaginosis
Performance and Safety of Lactal Gel for Treatment of Bacterial Vaginosis
The aim of this study is to find out how well the medical device Lactal Gel works and how safe it is. The product will be used to treat bacterial vaginosis in a group of fifty women aged 18 years or older.
- Trial name
- NCT07241871
- Testing
- Lactal Gel (Class IIa medical device)
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Rolf Kullgren AB
Vaginosis, Bacterial
Safety, Tolerability and Efficacy of Vaginal Suppository WO3191 in the Post-treatment of Bacterial Vaginosis
Bacterial Vaginosis (BV) is a common infectious disorder and is characterized by a disturbance in the vaginal microbiological milieu.
- Trial name
- NCT02687789
- Testing
- Medical Device: WO3191, Medical Device: Vagisan® Lactic Acid
- Where
- 13 sites in Germany
- Volunteers
- 43 people
- Sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
Oral Mucositis, Stem Cell Transplant Complications
Study of a New Medical Device for Oral Mucositis
This is a single-center randomized controlled trial of a new medical device (Bocaliner™) that has been designed to improve the treatment of chemotherapy-induced oral mucositis in patients undergoing cancer treatment.
- Trial name
- MDOM (NCT05104268)
- Testing
- Bocaliner
- Where
- Armenia
- Sponsor
- E2Bio Life Sciences, LLC
Device Replacement, Elective Replacement (ERI)
REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
The objective of this study is to prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a…
- Conditions
- Device Replacement, Elective Replacement (ERI), Device Advisory, Device Upgrade
- Trial name
- REPLACE (NCT00395447)
- Testing
- Straight-forward Device Replacement, Device Replacement with Upgrade
- Where
- 71 sites in United States
- Volunteers
- 1,744 people
- Sponsor
- Biotronik, Inc.
Suspected or Diagnosed Endotoxemia Casued by Gram-negative Bacteria
Remove LPS Registry
This registry will collect and validate regulatory-grade real-world data (RWD) on the usage of the LPS-Adsorber and the outcomes from using the LPS-Adsorber in various patient populations (various sub-registries) that also have…
- Trial name
- NCT05260099
- Testing
- LPS Adsorber
- Sponsor
- Alteco Medical AB
Bleeding, Bypass Complication
A Pre-market, Multi-center, International, Double-blind, Randomized, Two-arms, Controlled, Prospective Clinical Investigation Assessing the Safety and Performance of a Medical Device (ClearPlasma™) for the Treatment of Patients Undergoing Coronary Artery Bypass or Valve Replacement
Bleeding is a significant complication in cardiac surgery, with 10-15% of open cardiac surgery patients experiencing major intra- or post-operative bleeding.
- Conditions
- Bleeding, Bypass Complication, Valve Replacement
- Trial name
- NCT05542277
- Testing
- ClearPlasma
- Where
- 8 sites in Czechia, Israel and 1 more
- Volunteers
- 130 people
- Sponsor
- PlasFree Ltd.
Stent Complications
Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent.
This study evaluates the effectivity in urinary pH Control and the prevention of calcification in Double J stent using a device combined with the intake of dietary supplements.
- Trial name
- NCT03343275
- Testing
- Lit control pHDown
- Where
- 9 sites in Spain
- Volunteers
- 105 people
- Sponsor
- Devicare S.L.
Diabetic Foot Ulcer
Assessment of the Efficacy and Safety of a New Medical Device in the Local Treatment of Diabetic Foot Ulcers
Evaluation of the efficacy and safety of a device with LU3103209 compound versus the same device, free of LU3103209 compound, in the local management of DFUs.
- Trial name
- DISCOVERY (NCT03110796)
- Testing
- Dressing with LU3103209 - Dose 1, Dressing with LU3103209 - Dose 2, Dressing without LU3103209
- Where
- 6 sites in Czechia, France and 4 more
- Volunteers
- 210 people
- Sponsor
- Laboratoires URGO
Post-operative Pain
Pulsed Radiofrequency Energy to Treat Post-Bunionectomy Pain
Multicenter, randomized, controlled, double-blind study to evaluate the use of 3 days of pulsed radiofrequency energy (PRFE) to treat pain after bunionectomy surgery.
- Trial name
- NCT01694199
- Testing
- Pulsed Radiofrequency Energy (PRFE), No Pulsed Radiofrequency Energy (PRFE)
- Where
- 3 sites in United States
- Volunteers
- 139 people
- Sponsor
- Regenesis Biomedical, Inc.
Newborn Complication, Newborn Morbidity
Post-market Observation of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya
The goal of this study is to measure the clinical impact and cost-effectiveness of a wireless vital signs monitor, neoGuard, for hospitalized newborns at a tertiary healthcare facility in Kenya.
- Trial name
- NCT05728307
- Testing
- neoGuard vital signs monitor
- Where
- Kenya
- Volunteers
- 3,000 people
- Sponsor
- Assumpta Solome Nantume
Vaginal Disease
Post Marketing Follow Up Study To Evaluate Performance Safety Quality of Menopausal Transition Women Treated With Ainara
The objective of the present PMCF study with a 6 month follow up period is to identify potential new and unknown risks associated with longer term use of Ainara® and (considering the duration of symptoms in GSM) to collect…
- Trial name
- NCT04362371
- Testing
- Ainara
- Where
- Romania
- Volunteers
- 73 people
- Sponsor
- Italfarmaco
Intrauterine Devices
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).
- Trial name
- APEX IUD (NCT03754556)
- Testing
- Intrauterine device
- Where
- 4 sites in United States
- Volunteers
- 326,658 people, healthy volunteers welcome
- Sponsor
- Bayer
Bacterial Vaginosis (BV), Recurrent Bacterial Vaginosis
Evaluation of the Medical Device Vagitab - T as Adjuvant Therapy in Patients With Bacterial Vaginosis.
This clinical trial is looking at how well and safely the vaginal administration of Vagitab-T works . Vagitab-T is already on the market in several countries in Europe as a medical device.
- Trial name
- Vagitab (NCT06725888)
- Testing
- Vagitab -T vaginal tablets. Components: tyndallized probiotic L. plantarum HA-119, lactic acid, and xylo-oligosaccharides, lauryl glucoside, and macrogol 3350:
- Where
- Romania
- Volunteers
- 30 people
- Sponsor
- S.I.I.T. Srl
Vaginal Disease
Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness
This study evaluates the efficacy and safety of a new hyaluronic acid-based vaginal moisturizer gel to ease symptoms of vaginal dryness compared to a commonly used marketed vaginal moisturizer (Cumluade Hidratante Interno®).
- Trial name
- HYALU-LAUDE (NCT05888116)
- Testing
- Hidrante HA, Cumlaude Hidrante Interno®
- Where
- Spain
- Volunteers
- 54 people
- Sponsor
- Dermofarm, S.A.U
Vaginal Disease
Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®
This study evaluates treatment with the medical device Ainara® compared to a HA-based gel (Hyalogin) on the improvement of vaginal dryness
- Trial name
- NCT04245293
- Testing
- Ainara, HyaloGin
- Where
- Romania
- Volunteers
- 50 people
- Sponsor
- Italfarmaco
Intravenous Access, Medical Device
Safe-Infusion Study
Around 1.5 billion peripheral intravenous catheters (PIVCs) are sold yearly, with up to 90% of hospitalized patients receiving one, yet failure rates can reach 69%, often due to phlebitis, infiltration, occlusion, or…
- Trial name
- NCT06727240
- Testing
- Intervention
- Where
- 2 sites in Portugal, Spain
- Volunteers
- 548 people
- Sponsor
- Interlinked AB
Urinary Incontinence, Pelvic Floor Disorders
Performance and Safety of the PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment of Pelvic Static Disorders in Women With Urinary Incontinence.
The goal of this clinical trial is to evaluate the short-term improvement in urinary incontinence after perineo-sphincter rehabilitation using functional electrostimulation and biofeedback (PHENIX LIBERTY VIVALTIS device) in…
- Trial name
- IncontiLib (NCT05938855)
- Testing
- Electrical stimulation and biofeedback with the medical device Phenix Liberty
- Where
- 2 sites in France
- Volunteers
- 30 people
- Sponsor
- Vivaltis