Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333366
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-02-20
Brief Title:
First-In-Human Study of PDT to Detect IAH
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Intra-gastrointestinal Monitoring Device PDT to Detect Intra-Abdominal Hypertension IAH First-In-Human Study of Feasibility and Safety
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
PDT is a continuous pressure monitoring for Intra-Abdominal hypertension IAH designed to be less invasive than pan-endoscopic evaluation more tolerable than abdominal tapping and more effective than intravesical pressure measurement for IAH The PDT device consists of a piezoelectric sensor module with a low power Bluetooth wireless transmitter encased in biocompatible capsule The device will be swallowed after activation Following PDT insertion the patient is fitted with a custom removable external waist accessory containing a receiver which is worn during monitoring and provide PDT location by signal analysis with sufficient information to provide IAH trends
Detailed Description:
The participant will receive first phantom capsule after complete survey before the test which include standard clinical intra-vesical pressure measurement in the perioperative period of laparoscopic surgery The phantom capsule is an equal-weighted device of the same outer shell but without the electric circuits After the phantom capsule has been passed out the participant will receive the standard PDT capsule to record measured information continuously The date of the laparoscopic surgery should be within follow-up day 2 to day 6 Standard clinical intra-vesical pressure measurement will only be applied in the perioperative period of laparoscopic surgery The participant will still be monitored by standard PDT capsule afterwards After the PDT capsule passed out the participant will receive complete checkup again for comparison
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Application No2402020052 | OTHER | Chang Gung Memorial Hospital | None |