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NCT ID: NCT05883631 Recruiting - Atrial Fibrillation Clinical Trials

RESOLVE-AF: Clinical Evaluation of the Ablacathâ„¢ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.

RESOLVE-AF
Start date: October 23, 2023
Phase: N/A
Study type: Interventional

Demonstrate the safety and effectiveness of the Ablacathâ„¢ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation (AF) including paroxysmal or persistent or long-standing persistent, undergoing and De Novo or Redo procedures. Phenotype patients and demonstrate the prognostication power of Electrographic Flow (EGF®) maps among all subjects using 12-month follow-up outcomes following EGF-guided mapping and ablation.

NCT ID: NCT05883553 Recruiting - Clinical trials for Erectile Dysfunction

Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.

EROS
Start date: May 17, 2023
Phase: N/A
Study type: Interventional

Transgender and gender diverse (TGD) individuals most often choose for phalloplasty as a means to create masculine external genitalia. The neophallus created in phalloplasty is usually insufficient for penetrative sexual intercourse due to the lack of erectile structures. Therefore, implantation of an internal erectile prosthesis or use of an external device or epithesis is required. Internal prostheses are the main method for attaining penile rigidity after phalloplasty, but they carry a high risk of complications. Previous research has shown that up to 22% of prostheses for cisgender men were explanted due to various reasons, including infection, erosion, and malfunction within 20 months. The lack of reliable and durable erectile devices leads to a large proportion of patients either choosing phalloplasty but never going for the placement of an erectile prosthesis or completely abandoning the idea of GGAS under the form of phalloplasty. Secondarily, TGD individuals may be concerned about complication rates and likely need for additional surgeries associated with penile implant surgery. Therefore, alternative options for transgender and gender non-conforming patients after phalloplasty are needed. These alternatives may be surgical or non-surgical. External penile epitheses or penile splints were originally designed for cisgender men with erectile dysfunction but have been used experimentally by post-phalloplasty transgender men. While there is no data on the usability and durability of penile epitheses in a TGD population, they may be a viable alternative to an internal penile prosthesis after phalloplasty. Penile lifters or splints, marketed as ElatorTM or ErektorTM, are commercially available and consist of two rigid rings connected by rigid metal rods. The biggest of two rings is placed around the base of the phallus, and the second ring is placed behind the coronal ridge. By connecting the rods to the ring at the base of the penis, tension and rigidity between the two rings is created, allowing the user to penetrate their partner and remove the device after intercourse. The current study aims to extend the knowledge on these external devices by comparing them to the implantation of an internal penile prosthesis in post-phalloplasty transgender patients.

NCT ID: NCT05882877 Recruiting - Atopic Dermatitis Clinical Trials

A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

ROCKET-ASCEND
Start date: May 31, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.

NCT ID: NCT05882188 Recruiting - Infertility Clinical Trials

The Cost-effectiveness of Hysterosalpingography Versus Hysterosalpingo-foam Sonography During Fertility Work-up

FOil
Start date: September 22, 2023
Phase: N/A
Study type: Interventional

Hysterosalpingography (HSG) and hysterosalpingo-foam sonography are two methods to assess tubal patency during fertility work-up. This study aims to investigate the effectiveness of tubal flushing with oil-based contrast during HSG compared to tubal flushing during HyFoSy in women undergoing fertility work-up. The hypothesis is that tubal flushing with oil-based contrast during HSG leads to more live births than tubal flushing during HyFoSy.

NCT ID: NCT05881733 Recruiting - Atrial Fibrillation Clinical Trials

Effect of a Bigger Cryoballoon on the Total Antral Lesion Size: Evaluation of POLARx FIT

BETTER-FIT
Start date: October 2, 2023
Phase: N/A
Study type: Interventional

The investigators will prospectively evaluate the extent of antral lesion created by the 31 mm balloon size of a novel cryoballoon catheter (POLARx FIT). In 20 patients with paroxysmal atrial fibrillation, the investigators will perform pre- and post-ablation high-definition 3D maps to quantify the extent of lesion created by the 31 mm POLARx FIT cryoballoon.

NCT ID: NCT05880472 Recruiting - Pancreas Cancer Clinical Trials

Percutaneous Holmium Injection in Pancreatic Cancer

SLOTH-2a
Start date: May 2023
Phase: N/A
Study type: Interventional

This investigator initiated study with a medical device aims to assess the safety and feasibility of percutaneous injected holmium-166 microsphere brachytherapy in patients with irresectable pancreatic cancer.

NCT ID: NCT05878769 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Start date: June 28, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.

NCT ID: NCT05878483 Recruiting - Venipuncture Clinical Trials

Autonomous Blood Drawing Optimization and Performance Testing

ADOPT
Start date: July 21, 2023
Phase: N/A
Study type: Interventional

The purpose of this pre-market clinical study is to evaluate the performance (efficacy) and safety of an autonomous blood drawing device (Venipuncture Device). The study consists of several phases (A, B1, B2, C1, C2, 0). Phase B1 is a confirmatory, Pivotal Clinical Study, required for regulatory approval, in which non-inferiority should be demonstrated in comparison to manual blood drawing. Phases A, B2, C1, C2 are all exploratory studies, in which the technology and usability is further improved and tested. Phase 0 is an exploratory study for non-invasive technology testing (for example for improvement of ultrasound detection). The study locations are outpatient blood drawing departments, in which patients are included as subjects. Additionally, in Phase A and C1, a small number of volunteers is included in a non-hospital site (Vitestro Site).

NCT ID: NCT05878340 Recruiting - Healthy Clinical Trials

Miffy Eats the Rainbow

Miffy
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Fruit and vegetable (F&V) intake among children in western countries is below recommended levels. To increase F&V consumption in children (3-6 years), a novel method is proposed based on the concepts of repetitive taste exposure, role models, and non-food rewards guided by the dietary advice: "Eat the rainbow: go for color!" The aim is to determine the effect of this intervention to stimulate the consumption of color on the willingness to try different fruits and vegetables in 210 children aged 3-7 years old

NCT ID: NCT05877274 Recruiting - Clinical trials for Chronic Pain Syndrome

Sodium Channel Mutations in Patient With the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)

Nav-ACNES
Start date: October 3, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about sodium channel (Nav) mutations in patients with the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES). This study will give more insight into the pathophysiology of ACNES, which is still largely unknown. The primary objective is to determine if there are mutations of Nav1.7 and Nav1.8 in patients with ACNES. Therefore, one blood sample will be drawn, in which the mutations will be analyzed.