NCT05445206

Clinical Validation Study for CPM Device

Clinical Validation Study for Noninvasive Cardiopulmonary Management Device (Phase II)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Analog Device, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is designed to be a clinical validation study to ready the CPM System for FDA 510(k) submission. This study will be conducted as a prospective non-randomized. The study is non-significant risk since the CPM Device is noninterventional and noninvasive. The study is primarily designed to validate the accuracy of the respiration rate and the changes in relative tidal volume. All participants will be fitted with both the CPM Device as well as reference devices (capnography and ECG). Participants will be randomized between 4 procedures (A-D) which will determine the order of 18 exercises. Each exercise has about 2 minutes of device recording and two minutes of rest. Each exercise contains two positions: sitting up for one minute and lying down for one minute. For some exercises, the participant will be instructed to breathe at a certain rate (assisted by a metronome). For other exercises, the participants will breathe at a normal rate but change how deep the are breathing. For exercise 18, all capnography reference devices will be removed, and an ECG reference device will be placed. After exercise 18, the participant will have all devices removed and the study visit will terminate. The participant will receive a safety follow-up call about 1 week after their visit.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	CardioPulmonary Management Device (CPM)	CPM device is used in tangent with reference capnography device.

Timeline

• Start date: 2022-03-02
• Primary completion: 2022-07-06
• Completion: 2022-07-06
• First posted: 2022-07-06
• Last updated: 2024-06-12
• Results posted: 2024-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study