Intraabdominal PressureIAPNCT06709924
Evaluating Effectiveness of Elevated Intra-abdominal Pressure (IAP) by PressureDOT
An observational study of Intraabdominal Pressure, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 monthsHealthy volunteers can take part
- Conditions the study is for
- Intraabdominal Pressure
- What is being tested?
- EXERCISE TRAINING WITHOUT MEDICATION
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Nov 2024to 6 Dec 2024
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- healthy participants without previous surgical history
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- EXERCISE TRAINING WITHOUT MEDICATION
- Keywords
- Intraabdominal pressure, capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAINING WITHOUT MEDICATIONOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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.. Receives: 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.. Receives: Other: EXERCISE TRAINING WITHOUT MEDICATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety passage of capsule
monitor the passage rate of each participants and evaluate the risk for capsule retained rate.
Measured: 7days
Secondary outcomes (2)
Signal transmission of capsule
The pressure monitoring data transmission rate. We will collect all the signals from participants and calculate the data lost rate.
Measured: 2 days
Intraandominal pressure monitoring
The intraabdominal pressure were record when the capsule stay in the participants' body
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start25 Nov 2024
- Primary completion5 Dec 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intraabdominal PressureStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709924
- Sponsor's protocol ID
- CMUH113-REC2-139
- Acronym
- IAP
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2024
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 29135811Dietze-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.
PubMed 32574030
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Effectiveness of Elevated Intra-abdominal Pressure (IAP) by PressureDOT
- ClinicalTrials.gov ID
- NCT06709924
- Acronym / sponsor ID
- IAP / CMUH113-REC2-139
- Conditions
- Intraabdominal Pressure
- Keywords
- Intraabdominal pressure, capsule
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wrestling group | – | Other: EXERCISE TRAINING WITHOUT MEDICATIONThe 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.. |
| Swimming group | – | Other: EXERCISE TRAINING WITHOUT MEDICATIONThe 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.. |
Who may qualify
- Ages
- 20 to 65 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- healthy participants without previous surgical history
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXERCISE TRAINING WITHOUT MEDICATIONAfter 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. | Other | Swimming group, Wrestling group |
Primary outcome
Safety passage of capsule
Time frame: 7days
monitor the passage rate of each participants and evaluate the risk for capsule retained rate.
2 secondary outcomes
Signal transmission of capsule
Time frame: 2 days
Intraandominal pressure monitoring
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Results publication: PubMed 29135811de 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.
- Results publication: PubMed 32574030Dietze-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.
- Individual participant dataSharing planned: Undecided
Related trials for Intraabdominal Pressure
Recruiting
Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
Postoperative Delirium (POD), Intracranial Hypertension
Not yet recruiting
Synthetic Mesh for Prevention of HernIa After opEn Abdomen cLosure stuDy
Open Abdomen, Incisional Hernia
Not yet recruitingObservational study
Urinary Bladder Matrix (UBM) Registry
Tissue Repair, Soft Tissue Reconstruction
Not yet recruiting
Vacuum-Assisted Closure Versus Graduated Primary Skin Closure for Postoperative Burst Abdomen
Abdominal Wound Dehiscence, Burst Abdomen
Not yet recruiting
How Low Can You Go
Pelvic Organ Prolapse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraabdominal Pressure, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety passage of capsule (time frame: 7days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06709924, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.