Clinical trial NCT06709924: Evaluating Effectiveness of Elevated Intra-abdominal Pressure (IAP) by PressureDOT.
Official title: Evaluating Effectiveness of Elevated Intra-abdominal Pressure (IAP) by PressureDOT.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intraabdominal Pressure
Keywords: Intraabdominal pressure
capsule
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety passage of capsule
timeFrame: 7days
Secondary outcomes:
measure: Signal transmission of capsule
timeFrame: 2 days
measure: Intraandominal pressure monitoring
timeFrame: 2 days
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University &Hospital
Study officials:
References:
citation: 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.
citation: 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.