Evaluating Effectiveness of Elevated Intra-abdominal Pressure (IAP) by PressureDOT.

Recruiting

• Conditions: Intraabdominal Pressure

• Registration Number: NCT06709924
• Lead Sponsor: China Medical University Hospital

Brief Summary

To test the diagnostic efficacy of using the PressureDOT, an in-body real-time pressure-sensing smart capsule, in monitoring elevated intra-abdominal pressure in subjects.

This study aims to evaluate the PressureDOT (abbreviated as PDT, serial number: PD01), a state-of- the-art continuous pressure sensing system that is among the most advanced in the world. Unlike traditional methods of monitoring intra-abdominal pressure, such as indirectly measuring abdominal pressure by infusing saline into the bladder, PDT offers a minimally invasive, wireless solution intended to reduce the common risk of urinary tract infections associated with traditional methods and significantly decrease the need for manual operations.

The PDT capsule utilizes high-density circuit board technology and is protected by a unibody encapsulation that shields its internal components. This design enables the capsule to precisely and continuously monitor intra-abdominal pressure and temperature while transmitting data to an external receiving device wirelessly. Additionally, the external receiver is equipped with a special algorithm that can instantly track the capsule's speed of movement through the gastrointestinal tract, providing richer data support for clinical diagnosis.

Considering that elevated intra-abdominal pressure is a potential early high-risk factor for various diseases and closely related to the user's health status, this project plans to conduct a Phase I clinical trial across a broad spectrum of groups, including athletes, astronauts, vocalists, individuals undergoing rehabilitation, and any participants at risk of increased intra-abdominal pressure. These groups may face a risk of elevated intra-abdominal pressure due to their unique circumstances. Through this clinical trial, we hope to validate the effectiveness of PDT in the early diagnosis of elevated intra-abdominal pressure, reduce the long-term risk of exposure to high intra-abdominal pressure for participants, and further alleviate the burden on medical practitioners, thereby reducing medical costs.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-25
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-28
• Last Update Posted: 2024-11-28
• Primary Completion: 2025-04
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• healthy participants without previous surgical history

Exclusion Criteria

• previous abdominal surgical history
• GI obstruction history
• no need of magnetic resonance imaging in two weeks after capsule ingestion.
• history of swallowing difficulty, dysphagia, odynophagia.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety passage of capsule	7days	monitor the passage rate of each participants and evaluate the risk for capsule retained rate.

Secondary Outcome Measures

Name	Time	Method
Signal transmission of capsule	2 days	The pressure monitoring data transmission rate. We will collect all the signals from participants and calculate the data lost rate.
Intraandominal pressure monitoring	2 days	The intraabdominal pressure were record when the capsule stay in the participants' body

Trial Locations

Locations (1)

China Medical University &Hospital; 🇨🇳 Taichung, Taiwan