Evaluating Effectiveness of Elevated Intra-abdominal Pressure (IAP) by PressureDOT.
NCT ID: NCT06709924
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
20 participants
OBSERVATIONAL
2024-11-25
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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..
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..
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* GI obstruction history
* no need of magnetic resonance imaging in two weeks after capsule ingestion.
* history of swallowing difficulty, dysphagia, odynophagia.
20 Months
65 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
China Medical University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
China Medical University &Hospital
Taichung, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ming-Che Hsin, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CMUH113-REC2-139
Identifier Type: -
Identifier Source: org_study_id