First-In-Human Study of PDT to Detect IAH

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06333366
Study type	Interventional
Source	Chang Gung Memorial Hospital
Contact	Dong-Ru Ho, MD, PhD
Phone	886-975353211
Email	redoxdrh@gmail.com
Status	Recruiting
Phase	N/A
Start date	February 18, 2024
Completion date	September 20, 2025

View Details

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