CIED Implantation in Low BMI Patients

Status Withdrawn

Clinical Trial Summary

The primary objective is to demonstrate a better degree of healing at the incision site and a decrease in erosion with CanGaroo compared to control patients (no envelope, CIED alone).

Clinical Trial Description

A single-center, prospective, randomized, post-market study of patients undergoing implantation of a pacemaker, ICD, or S-ICD with or without CanGaroo using the same hydration solution. Twenty patients, randomized 1:1 for 10 in the treatment group and 10 in the control group, shall be enrolled. Follow-up visits include post-op and 3-months following the implantation procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04299282
Study type	Interventional
Source	Aziyo Biologics, Inc.
Contact
Status	Withdrawn
Phase	N/A
Start date	June 2021
Completion date	March 2022

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