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

NCT06709924 | Completed

• 1 other identifier: CMUH113-REC2-139
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraabdominal Pressure

Keywords

Intraabdominal pressure; capsule

Outcome Measures

Primary Outcomes (1)

• Safety passage of capsule

  monitor the passage rate of each participants and evaluate the risk for capsule retained rate.

  7days

Secondary Outcomes (2)

• Signal transmission of capsule

  2 days

• Intraandominal pressure monitoring

  2 days

Study Arms (2)

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

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

Interventions

EXERCISE TRAINING WITHOUT MEDICATION OTHER

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; Wrestling group

Eligibility Criteria

• Age: 20 Months - 65 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• healthy participants without previous surgical history

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University &Hospital

Taichung, 40454, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 29135811 RESULT

• 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.

  PMID: 32574030 RESULT

MeSH Terms

Interventions

Exercise; Dosage Forms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: November 25, 2024
• Primary Completion: December 5, 2024
• Study Completion: December 6, 2024
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

TW (1)