Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05867914
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2023-05-01
Brief Title:
Early Feasibility Study Evaluating the 3P-100 Device in Subjects With PH-ILD
Sponsor:
Third Pole Therapeutics Inc
Organization:
Third Pole Therapeutics Inc
Study Overview
Official Title:
A Within-subject Device-setting Escalation Early Feasibility Study Evaluating the Safety Tolerability and Functionality of 3P-100 in Subjects With PH-ILD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EFS
Brief Summary:
A trial to evaluate the safety tolerability and functionality of 3P-100 in subjects with Pulmonary Hypertension PH accompanying Interstitial Lung Disease ILD PH-ILD
Detailed Description:
This is a multi-center early feasibility study evaluating the safety and tolerability of the 3P-100 device which creates and delivers iNO 2 mghr and 6 mghr for the treatment of subjects with PH-ILD All subjects will use the 3P-100 device and receive iNO 2 mghr and 6 mghr via the 3P-100 device aiming for 4-45 hours of treatment across both device settings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None