Site Startup Documents
CONFORM IDE Trial NCT05147792
Welcome New Sites Participating in the CONFORM IDE Trial
Use the links below to download documents from the CONFORM Trial startup binder.
Protocols & ICF Documents
Protocol Rev. K
17Dec2024
Protocol Synopsis Rev. K
17Dec2024
CONFORM Pivotal TEE Imaging Acquisition Protocol
V. 6.0 12Mar2024
CONFORM Angio Protocol
V1.0 13Apr2023
CONFORMAL CT Acquisition Protocol Rev. A
15Jun2022
Template Consent Form S6_Rev G
V. 1.0 05Mar2024
CONFORM Template ICF Rev. K
17Dec2024
Budget & CTA Documents
CONFORM Pivotal Payment Terms Template
V. 6.1 Mar25
CONFORM Pivotal Trial Detailed Budget Rev. K
V9.1 Mar25
CONFORM Investigator Agreement (US)
V. 2.0 Mar2025
Conformal - Pivotal Clinical Trial Agreement Template
V. 8.0 6Mar2024
Conformal Medical CONFORM IDE Reimbursement Guide
V. 1.0 15Jul2022
Conformal Medical CONFORM IDE study - Sample Prior Authorization Letter
V. 1.0 Mar2025
F-90 Financial Disclosure Form Rev. B
Mar2025
W9 Conformal Medical
Mar2025
Subject Injury Language Support
CED Approval CONFORMAL Pivotal Trial letter
23Mar2022
Subject Injury Language Support
Medicare National Coverage Determination
07Sept2007
Subject Injury Language Support
Subject Injury Language Rationale
23Mar2022
CMS—No Cost Device Amount to Place on Claim
MLN909368 May2022
FDA & CMS Approval Documents
CED Approval CONFORM IDE Trial Letter
23Mar2022
FDA Approval, Supplement 016/A001
22Dec2021
FDA Approval, Supplement 033
13Dec2023
FDA Approval Letter to Resume CONFORM IDE Trial
20Dec2024
Instructions for Use Documents
CLAAS System IFU Rev. L
12May2025
Patient Facing Materials
Please make sure your IRB has approved the use of these materials.
CLAAS Device for Demonstration
CONFORMAL Clinical Trial Poster Rev. C
Conformal Medical Implant Card Rev. B
Conformal Medical Patient Brochure Rev. C
Conformal Medical Patient Magnet Rev. A
Implant Flipbook Conform Pivotal
CONFORM IDE Trial Regulatory Binder
Use the link below to download the full CONFORM Trial Regulatory binder.
20MAY2025
