Clinical Use Study of SAPH Device for Patent Hemostasis After a Transradial Procedure
NCT06991010 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-07-15
Summary
This is a prospective, multicenter study intended to provide supportive clinical information on the use of the SAPH device to achieve radial artery patent hemostasis after a transradial procedure.
Conditions
- Hemostasis of Arterial Punctures
Interventions
- DEVICE
-
Suction-Activated Patent Hemostasis (SAPH) Device
A compression device intended to achieve patient hemostasis of the radial artery
Sponsors & Collaborators
-
RARAS CRO
collaborator UNKNOWN -
Transradial Technologies, LLC
lead INDUSTRY
Principal Investigators
-
Regulatory and Clinical Lead, PhD · Transradial Technologies, LLC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-01
- Primary Completion
- 2025-10-28
- Completion
- 2025-11-28
- FDA Device
- Yes
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