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NCT ID: NCT05363813 Active, not recruiting - Laparoscopy Clinical Trials

Post-market Clinical Follow-up Study of Reusable Clip Applier Cartridge Devices for LAParoscopic Surgery

RELAP
Start date: October 17, 2022
Phase: N/A
Study type: Interventional

This is a Post-Market Clinical Follow-up (PMCF) investigation to determine the long-term effectiveness and safety of the Multi-Fire Clip System in laparoscopic surgery. This system consists of two medical devices, the M/L-10 Clip Applier and the M/L-10 Clip. The Multi-Fire Clip System is indicated for occluding and ligating vessels, ducts, tracts and other tubular structures during laparoscopic and general surgical procedures. This medical device has been marketed in Europe since 2006 and in the United States since 2002, among other places. Laparoscopic surgeries have become the standard of excellence for many surgical procedures as they allow the intervention to be performed in a minimally invasive way, which means significant improvements in factors such as postoperative pain or length of hospital stay compared to open surgeries. Laparoscopic procedures require the use of different hemostatic techniques to minimize blood loss or leakage of other fluids through their respective ducts. Currently, clip and staple placement are the most commonly used procedures for ligation and/or occlusion of blood vessels and other tubular structures. In this context, the Multi-Fire Clip System is presented as an alternative device that can produce significant cost savings due to the reusable design of the M/L-10 Clip Applier. It also provides precise control of bleeding during surgery, which could lead to less potential injury to surrounding structures. The present clinical trial is a PMCF study to evaluate the long-term safety and efficacy of the Multi-Fire Clip System in patients scheduled to undergo laparoscopic surgery in which clip placement is anticipated. During the surgery procedure, the necessary clips will be placed using the aforementioned multi-shot clip system. Participants will be followed up for 6 months after the operation. Through an on-site visit and a telephone call visit, data on possible adverse events related to the device or procedure will be collected in order to assess the long-term safety and efficacy of these devices.

NCT ID: NCT05354440 Active, not recruiting - Prostate Cancer Clinical Trials

Post Marketing Clinical Follow Up of the BioProtect Balloon Implant System

CLP-10441
Start date: January 1, 2022
Phase:
Study type: Observational

Long-Term Prospective Post Marketing Clinical Follow Up for Evaluation of the BioProtect Balloon Implant™ System

NCT ID: NCT05350072 Active, not recruiting - Sjogren Syndrome Clinical Trials

Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

NEPTUNUS-1
Start date: July 28, 2022
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-1)

NCT ID: NCT05338970 Active, not recruiting - Clinical trials for Nonsquamous Non-small Cell Lung Cancer

HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

Start date: July 8, 2022
Phase: Phase 3
Study type: Interventional

Disease progression is typical for patients with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Standard platinum-based chemotherapy offers limited efficacy and an unfavorable safety profile.There is an urgent need for more effective and tolerable therapies for patients with EGFRm NSCLC who have exhausted available targeted therapies. Clinical evidence suggest that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC.

NCT ID: NCT05331183 Active, not recruiting - Cystic Fibrosis Clinical Trials

Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del

Start date: November 23, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the long-term safety, efficacy and pharmacodynamics of ELX/TEZ/IVA in participants with cystic fibrosis (CF) with at least 1 non-F508del ELX/TEZ/IVA-responsive CF transmembrane conductance regulator (CFTR) gene mutation.

NCT ID: NCT05321082 Active, not recruiting - Clinical trials for Lung Diseases, Interstitial

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

Start date: October 5, 2022
Phase: Phase 3
Study type: Interventional

This study is open to adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study. If they already take nintedanib, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with PF-ILD. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine. Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT05321069 Active, not recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

Start date: September 19, 2022
Phase: Phase 3
Study type: Interventional

This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with IPF. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine. Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT05310071 Active, not recruiting - Alzheimer's Disease Clinical Trials

A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease

ENVISION
Start date: June 2, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's disease.

NCT ID: NCT05285982 Active, not recruiting - Clinical trials for Lung Diseases, Interstitial

A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON)

Start date: April 4, 2022
Phase: Phase 3
Study type: Interventional

This study is open to children and adolescents with interstitial lung disease (ILD) that causes lung fibrosis. This is a study for people who took part in a previous study (study 1199-0337, InPedILD™) and for people who are between 6 and 17 years old and have fibrosing ILD. This study tests a medicine called nintedanib. Nintedanib is already used to treat different types of lung fibrosis in adults. The purpose of the study is to find out how well long-term treatment with nintedanib is tolerated in children and adolescents. All participants take nintedanib capsules twice a day. Participants are in the study for at least 1 year and 5 months or until nintedanib or other treatment options become available outside of this study. During the first 3 years, they visit the study site about 15 times. Afterwards, they visit the study site every 3 months. The doctors collect information on any health problems of the participants.

NCT ID: NCT05270044 Active, not recruiting - Melanoma Clinical Trials

Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.

COLUMBUS-AD
Start date: May 2, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).