Trials / Withdrawn
WithdrawnNCT04299282
CIED Implantation in Low BMI Patients
A Prospective, Randomized, Single-Center Study Evaluating CanGaroo in Low BMI Patients Undergoing Pacemaker, ICD, or S-ICD Implantation
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Elutia Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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).
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CanGaroo | CIED ECM envelope |
Timeline
- Start date
- 2021-06-01
- Primary completion
- 2021-12-01
- Completion
- 2022-03-01
- First posted
- 2020-03-06
- Last updated
- 2025-05-16
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04299282. Inclusion in this directory is not an endorsement.