RecruitingNot ApplicableNCT06333366

First-In-Human Study of PDT to Detect IAH

Intra-gastrointestinal Monitoring Device (PDT) to Detect Intra-Abdominal Hypertension (IAH): First-In-Human Study of Feasibility and Safety

Sponsor

Chang Gung Memorial Hospital

Enrollment

10 participants

Start Date

Feb 18, 2024

Study Type

INTERVENTIONAL

Conditions

Intra-Abdominal Hypertension

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.

Eligibility

Min Age: 20 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This first-in-human study is testing a small swallowable capsule device (called a PDT) that can measure pressure inside the abdomen. Researchers want to see if this device can safely detect elevated abdominal pressure during laparoscopic (keyhole) surgery. **You may be eligible if...** - You are between 20 and 80 years old - You are already scheduled for laparoscopic (keyhole) surgery - Your BMI is between 15 and 35 kg/m² - You are willing and able to follow all study requirements **You may NOT be eligible if...** - You have a condition that could cause the capsule to get stuck in your intestines (such as a history of bowel blockage or certain prior abdominal surgeries) - You need an MRI within 7 days of swallowing the capsule - You have serious heart failure, kidney failure, or severe liver disease - You have hepatitis B, hepatitis C, or HIV - You have a pacemaker or other implanted electrical device - You are pregnant or planning to become pregnant - You have difficulty swallowing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntra-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.

Locations(1)

Dong-Ru Ho

Chiayi City, Taiwan

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NCT06333366

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