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First-In-Human Study of PDT to Detect IAH

NCT06333366 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-03-27

No results posted yet for this study

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.

Conditions

  • Intra-Abdominal Hypertension

Interventions

DEVICE

Intra-gastrointestinal monitoring device (PDT)

The PressureDOT(PDT) is an active intra-gastrointestinal device, that is intended to be introduced in the gastrointestinal tract, approximately along whole. The device is battery powered. The signal is wirelessly transmitted through outside the body and received by waist receiver, using an antenna array applied to the skin with a protection guard at the level of the abdomen.

Sponsors & Collaborators

  • DOTSPACE

    collaborator UNKNOWN

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-18
Primary Completion
2024-07-16
Completion
2025-09-20

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06333366 on ClinicalTrials.gov