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

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.

Study Overview

• Status: Completed
• Conditions: Intraabdominal Pressure
• Intervention / Treatment: Other: EXERCISE TRAINING WITHOUT MEDICATION

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40454
    • China Medical University &Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The exercise expertises who can ingest capsules without swelling difficulty and can cooperate the monitoring procedure. The age must be above 20 years.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Wrestling group; The ten participants who are expertise of wrestling and strong core muscle usage. After ingest the capsule, the signal transmission and intraabdominal pressure parameters were collected from receivers outside..	Other: EXERCISE TRAINING WITHOUT MEDICATION; After ingesting the capsular sensor, the participants were request to perform exercise packages and monitor the change of signal transmission rate and shift of intraabdominal pressure level.
Swimming group; The ten participants who are expertise of swim and strong core muscle usage. After ingest the capsule, the signal transmission and intraabdominal pressure parameters were collected from receivers outside..	Other: EXERCISE TRAINING WITHOUT MEDICATION; After ingesting the capsular sensor, the participants were request to perform exercise packages and monitor the change of signal transmission rate and shift of intraabdominal pressure level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety passage of capsule	monitor the passage rate of each participants and evaluate the risk for capsule retained rate.	7days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Publications and helpful links

General Publications

• de Gennaro JD, de Gennaro CK, Shaw JM, Petelenz TJ, Nygaard IE, Hitchcock RW. The Relationship Between Intra-Abdominal Pressure and Body Acceleration During Exercise. Female Pelvic Med Reconstr Surg. 2019 May/Jun;25(3):231-237. doi: 10.1097/SPV.0000000000000523.
• Dietze-Hermosa M, Hitchcock R, Nygaard IE, Shaw JM. Intra-abdominal Pressure and Pelvic Floor Health: Should We Be Thinking About This Relationship Differently? Female Pelvic Med Reconstr Surg. 2020 Jul;26(7):409-414. doi: 10.1097/SPV.0000000000000799.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Actual): December 5, 2024
• Study Completion (Actual): December 6, 2024

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: capsule; Intraabdominal pressure
• Additional Relevant MeSH Terms: Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmaceutical Preparations; Investigative Techniques; Technology, Pharmaceutical; Exercise; Dosage Forms
• Other Study ID Numbers: CMUH113-REC2-139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No