Post-Approval Studies (PAS) Database

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Continued Follow up of the IDE (DOORwaY) Subjects

General
Study Status	Study Pending
Application Number / Requirement Number	P990065 S014/ PAS001
Date Original Protocol Accepted	07/01/2025
Date Current Protocol Accepted
Study Name	Continued Follow up of the IDE (DOORwaY) Subjects
Device Name	SIR-Spheres Y-90 resin microspheres
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	Objective Performance Criterion
Analysis Type	Analytical
Study Population	Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives	This study is a single arm, multicenter, prospective study that consists of continued follow-up of all available subjects from the IDE Pivotal Study (DOORwaY90, STX2001, revision F). The objective of the DOORwaY90 study is to evaluate the safety and effectiveness of selective internal radiation therapy using SIR-Spheres Y-90 resin microspheres as first-line treatment for local control of hepatocellular carcinoma (HCC) in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1, B2, and C.
Study Population	Patients diagnosed with HCC, no macrovascular invasion, Child Pugh-A cirrhosis, BCLC stage A, B1, B2, and C with maximal single lesion size of less than or equal to 8 cm, and who are not considered suitable for treatment by resection or eligible for ablation at time of study entry.
Sample Size	100 subjects treated (up to 150 consented)
Key Study Endpoints	Co-primary Effectiveness Endpoints - Overall response rate (ORR) using a localized version of modified Response Evaluation Criteria in Solid Tumors (“localized mRECIST”) criteria and best response through 9 months. - Duration of response (DoR), defined as the interval from first time of response (partial response (PR) or complete response (CR)) until disease progression (PD), as defined by localized mRECIST criteria Secondar Endpoints - Grade greater than or equal to 3 toxicity (CTCAE v5.0) at 2 months and 6 months - Incidence of liver resection - Incidence of liver transplant - Quality of life metrics: Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire EQ-5D-5L questionnaire
Follow-up Visits and Length of Follow-up	24 months

Continued Follow up of the IDE (DOORwaY) Subjects Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	02/27/2026

Contact Us

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Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background