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NCT ID: NCT05148390 Completed - Diabetic Foot Ulcer Clinical Trials

Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice

GELFI
Start date: April 24, 2022
Phase:
Study type: Observational

This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e. within its intended purpose and without any additional invasive or stressing examinations for the patients. Up to 36 adult patients with wounds suitable to be treated with the medical device and meeting the inclusion/exclusion criteria will be enrolled at two participating German sites. During 5 on-site visits within 28 days routine weekly dressing changes the Health Care Professional will examine the wound and will perform required wound care and dressing changes. Pictures of the wound with and without dressing will be taken at each visit and used for automatic analysis. The subjects will be asked to rate their general wound pain and the pain perceived during dressing changes. A wound-related quality of life questionnaire will be presented to the subjects twice and the subject and HCP will rate their safisfaction with the product.

NCT ID: NCT05146661 Completed - Clinical trials for Cardiovascular Diseases

NEURESCUE Device as an Adjunct to Cardiac Arrest

ARISE-EU
Start date: August 11, 2022
Phase: N/A
Study type: Interventional

The NEURESCUE device is the first intelligent balloon catheter for aortic occlusion, an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment. The catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the descending to redirect blood flow towards the upper body. The objective of the study is to investigate the safety and performance of the NEURESCUE device as an adjunct to Advanced Life Support (ALS) in adults with cardiac arrest.

NCT ID: NCT05141123 Completed - Aneurysm Abdominal Clinical Trials

Registry of Patients Treated by Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures

Start date: October 30, 2022
Phase:
Study type: Observational

The aim of the study is to evaluate the outcomes of the preloaded stent-graft design (PLD) in the routine treatment of para-renal and thoraco-abdominal aneurysms. Results and postoperative events are reported in accordance with the current reporting standards for endovascular aortic repair prepared and revised by the Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery. The Registry will include approximately 300 patients treated from January 2015 to May 2021 (retrospective arm) and June 2021 to June 2023 (perspective arm) for the routine treatment of para-renal and thoraco-abdominal aneurysms. To reach 300 patients, the enrollments can be extended until June 2026.

NCT ID: NCT05139810 Completed - Clinical trials for Hereditary Angioedema

OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)

Start date: December 3, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of donidalorsen in participants with HAE and effect of donidalorsen on the quality and pattern of HAE attacks and their impact on quality of life (QoL).

NCT ID: NCT05138679 Completed - Acute Limb Ischemia Clinical Trials

Evaluation of Acute Lower Limb Ischemia

PROMOTE-ALI
Start date: December 1, 2021
Phase:
Study type: Observational

The primary objective of this study is to evaluate the effect of different treatment modalities on clinical outcome of patients suffering from acute lower limb ischemia (ALI). Depending on clinical presentation, anatomical as well as technical considerations, different treatment options are available for revascularisation of affected limbs. Using an observational, international, multicentric study design (min. patient number of 500), the defined primary endpoint of the study, amputation-free survival 90 days after the diagnosis of ALI, will be evaluated.

NCT ID: NCT05137639 Completed - Clinical trials for Head and Neck Cancer

Free Skin Grafting to Reconstruct Donor Sites After Radial Forearm Flap Harvesting

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Reconstruction of the donor site after radial forearm flap harvesting is a common procedure in maxillofacial plastic surgery. Unfortunately, free skin graft transplantation faces wound healing impairments such as necrosis, (partial) graft loss, or tendon exposure. Several studies have investigated methods to reduce these impairments and demonstrated improvements if the wound bed is optimized. However, these methods are device-dependent, expansive, and time-consuming. Therefore, the application of platelet-rich fibrin (PRF) to the wound bed could be a simple, cost effective, and device-independent method to optimize wound-bed conditions instead. In this study, PRF membranes were applied between the wound bed and skin graft.

NCT ID: NCT05137041 Completed - Low Back Pain Clinical Trials

Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain

IRPATCH
Start date: November 4, 2021
Phase: Phase 3
Study type: Interventional

Primary Objective: To assess the efficacy of the infrared therapy patch (ITP) FIRTECH for treating participants suffering from mild to moderate acute low back pain. Secondary Objectives: - To assess the efficacy of ITP FIRTECH on participant disability - To assess the efficacy of ITP FIRTECH on the degree of participant mobility - To assess the safety of ITP FIRTECH

NCT ID: NCT05135936 Completed - Fibromyalgia Clinical Trials

Hyperthermia in Fibromyalgia Syndrome

HYPAIN
Start date: November 12, 2020
Phase: N/A
Study type: Interventional

This study will examine the effectiveness of water-filtered whole-body hyperthermia during an outpatient setting in patients with fibromyalgia. The duration of the study is about 3 weeks with two treatment units per week and a passive period (follow-up measurement) of 24 weeks after the outpatient setting.

NCT ID: NCT05135208 Completed - Radiation Dosage Clinical Trials

Optimized Camera-based Patient Positioning in CT

Start date: February 1, 2021
Phase:
Study type: Observational

To evaluate the effect on radiation dose using intelligent camera positioning in comparison to manual positioning by the radiology assistant.

NCT ID: NCT05135000 Completed - Clinical trials for Pulmonary Arterial Hypertension

Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension

Start date: June 30, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to explore the efficacy and safety of LTP001 in participants with pulmonary arterial hypertension (PAH) to determine if LTP001 has an adequate clinical profile to warrant further clinical development in this indication.