Clinical Trials Logo
  1. Home
  2. Bleeding
  3. NCT04218292
  4. Details
NCT04218292 Clinical Trial

Micro Plug Set - Post Market Clinical Follow-up (PMCF) Plan

Bleeding Clinical Trial

Official title:
Dr. Amplatz Micro Plug - Post Market Clinical Follow-up (PMCF) Plan

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04218292
Other study ID # PMCF 24October2019
Secondary ID KAM-P4-21-01
Status Active, not recruiting
Phase
First received
Last updated
Start date March 31, 2020
Est. completion date February 28, 2022

Study information
Verified date April 2021
Source KA Medical, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational, post market clinical follow-up (PMCF) intended to evaluate the residual risks of the Micro Plug Set which is intended for use during arterial embolization of the peripheral vasculature. This PMCF will collect data pertaining to any adverse events as well as the identification of any unanticipated risks up to the first 12 months following device implant.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date February 28, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subject is scheduled for arterial embolization in the peripheral vasculature. - Subject is greater than 18 years of age Exclusion Criteria: - Subject is unable to give informed consent - Subject is pregnant or breastfeeding - Subject has allergy to nickel - Patient requires neurologic or cardiac use of an occlusion device, contrary to the Micro Plug Set Instructions For Use.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Micro Plug Set
The Micro Plug Set is indicated for arterial embolization in the peripheral vasculature.

Locations
Country Name City State
Germany University Hospital Magdeburg Magdeburg

Sponsors (2)
Lead Sponsor Collaborator
KA Medical, LLC Merit Medical Systems, Inc.

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of serious device-related and procedure-related adverse events Rate of serious device-related and procedure-related adverse events 12 months
Secondary Rate of successful delivery of the device Rate of successful delivery of the Micro Plug device to the intended position. 1 day
See also
  Status Clinical Trial Phase
Completed NCT04058223 - Comparison of the Short-term Outcomes of Using DST and PPH Staplers in the Treatment of Grade III and IV Hemorrhoids
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT05669313 - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Completed NCT04590898 - Peri-device Leakage Closure After LAAO
Active, not recruiting NCT05563883 - Atrial Fibrillation and Cancer: a Nationwide French Cohort Study
Not yet recruiting NCT04537533 - Tranexamic Acid Infusion in Low Dose Versus in High Dose for Reducing Blood Loss in Radical Cystectomy Operations Phase 4
Withdrawn NCT02851940 - Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids N/A
Completed NCT02722720 - Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral N/A
Recruiting NCT02279186 - Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section Phase 4
Active, not recruiting NCT02244853 - Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease N/A
Completed NCT02092415 - Assessment of Limb Perfusion During Junctional Tourniquet N/A
Completed NCT02980497 - Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study N/A
Completed NCT02245854 - Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps N/A
Not yet recruiting NCT01438736 - Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern? Phase 4
Completed NCT00515541 - Lovaza's Effect on the Activation of Platelets Phase 2
Completed NCT00143715 - Oral Vitamin K for Warfarin Associated Coagulopathy Phase 3
Terminated NCT03954314 - DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery Phase 3
Recruiting NCT05945680 - Tranexamic Acid in Breast Esthetic Surgery. Phase 4
Recruiting NCT03783182 - Betamethasone (Betapred®) as Premedication for Reducing Postoperative Vomiting and Pain After Tonsillectomy Phase 4
Not yet recruiting NCT05464394 - Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass Phase 3