Intra-Abdominal HypertensionNCT06333366
First-In-Human Study of PDT to Detect IAH
A study testing Intra-gastrointestinal monitoring device (PDT) in people with Intra-Abdominal Hypertension, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
PDT is a continuous pressure monitoring for Intra-Abdominal hypertension (IAH) designed to be less invasive than pan-endoscopic evaluation, more tolerable than abdominal tapping, and more effective than intravesical pressure measurement for IAH. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Intra-Abdominal Hypertension
- What is being tested?
- Intra-gastrointestinal monitoring device (PDT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Feb 2024to 20 Sep 2025
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient volunteer planning for laparoscopic surgery
- Subjects willing to sign an informed consent form (ICF),
- Adult subjects, age ≥ 20 and age ≤ 80 years old
- BMI between 15（kg/m2）- 35（kg/m2）
- Subjects willing to comply to study protocol requirements (blood pressure measurement, diet, alcohol, study visits, blood sampling, etc.)
- Patient who had been scheduled for any laparoscopic surgery which may alter intra-abdominal pressure.
- Patient volunteer planning for laparoscopic surgery, as self-declared and confirmed by screening assessments and Principal Investigator's judgment
Who cannot join
- Patients with a high risk for capsule retention (such as intestinal diverticula, acute abdominal pain without regular defecation indicating intestinal obstruction or a history of abdominal operation or intestinal reconstructed operation),
- Any evidence that occlusion of gastrointestinal tract is obvious or severe paralytic ileus that may result in intra-abdominal hypertension in need of immediate surgical intervention not caused by base of tongue (i.e., central apnea, neurologic disorder, retropalatal collapse, nasal obstruction)
- Any condition that subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- Any factor that, in the surgeon's judgment, would pose a risk to surgery or placement of an intra-gastrointestinal monitoring device
- Any factor that, in the surgeon's judgment, would make the subject unlikely to respond to PDT insertion and pressure measurement.
- Congenital anomalies of gastrointestinal tract or any other anatomical abnormality of the head, neck, chest, or abdomen that would be a contraindication to placement of the PDT device and usage of the external device
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- There are no exclusion criteria based on gender, race or ethnicity
- Patients with a history of Crohn's disease i* Patients with serious systematic diseases such as congestive heart failure, renal failure or severe liver disease.
- Any blood disorder identified by haematocrit <30% or >55%
- History of hepatitis B, hepatitis C, or HIV
- Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
- Female subjects who are pregnant, planning on becoming pregnant or nursing
- Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
- Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication
- The presence of any other active implanted device, such as cardiac pacemaker or other implanted electro medical devices.
- The presence of any other wireless sensor or transmitter located in abdomen (excluding compatible device also for pressure sensing and other location is acceptable)
- Impaired fasting glucose or impaired glucose tolerance (for Patient volunteer planning for laparoscopic surgery)
- Any contraindication to the use of the PDT system as listed in the device Instructions for Use (IFU) (i.e. any known allergy to PDMS)
- Subject has dysphagia
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Dong-Ru Ho
Chiayi City, 60061
Dong-Ru Ho, MD, PhD, 886-975353211, redoxdrh@gmail.com
redoxdrh@gmail.com
About this study
Official title: Intra-gastrointestinal Monitoring Device (PDT) to Detect Intra-Abdominal Hypertension (IAH): First-In-Human Study of Feasibility and Safety
PDT is a continuous pressure monitoring for Intra-Abdominal hypertension (IAH) designed to be less invasive than pan-endoscopic evaluation, more tolerable than abdominal tapping, and more effective than intravesical pressure measurement for IAH. The PDT device consists of a piezoelectric sensor module with a low power Bluetooth wireless transmitter encased in biocompatible capsule. The device will be swallowed after activation. Following PDT insertion, the patient is fitted with a custom, removable external waist accessory containing a receiver, which is worn during monitoring and provide PDT location by signal analysis with sufficient information to provide IAH trends.
Read the detailed description
The participant will receive first phantom capsule after complete survey before the test, which include standard clinical intra-vesical pressure measurement in the perioperative period of laparoscopic surgery. The phantom capsule is an equal-weighted device of the same outer shell but without the electric circuits. After the phantom capsule has been passed out, the participant will receive the standard PDT capsule to record measured information continuously. The date of the laparoscopic surgery should be within follow-up day 2 to day 6. Standard clinical intra-vesical pressure measurement will only be applied in the perioperative period of laparoscopic surgery. The participant will still be monitored by standard PDT capsule afterwards. After the PDT capsule passed out, the participant will receive complete checkup again for comparison.
- Conditions
- Intra-Abdominal Hypertension
- Being tested
- Intra-gastrointestinal monitoring device (PDT)
- Keywords
- Intra-Abdominal hypertension, Intravesical pressure, Intra-gastrointestinal monitoring device, laparoscopic surgery, Abdominal compartment Syndrome
- Medical subject headings
- Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-gastrointestinal monitoring device (PDT)Device
The PressureDOT(PDT) is an active intra-gastrointestinal device, that is intended to be introduced in the gastrointestinal tract, approximately along whole. The device is battery powered. The signal is wirelessly transmitted through outside the body and received by waist receiver, using an antenna array applied to the skin with a protection guard at the level of the abdomen.
| Study group | Role | What they receive |
|---|---|---|
| intraabdominal pressure (IAP) monitor | Experimental | Patient who will take laparoscopic surgery will be checked for intra-abdominal pressure, intra-vesical pressure, and intra-gastrointestinal pressure ri-operative stage. PDT passage time will be checked. Receives: Device: Intra-gastrointestinal monitoring device (PDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of device-related or sensor insertion/removal procedure-related adverse events
evaluating of incidence of adverse event (AE)
Measured: 15 days
Rate of foreign body reaction due intra-gastrointestinal insertion
evaluating GI symptoms
Measured: 15 days
Rate of GI symptoms, i.e. inflammation, infection, diarrhea, bowel obstruction, and ileus
evaluating safety
Measured: 15 days
Incidence of sensor failure
evaluating stability of device
Measured: 15 days
Secondary outcomes (4)
Percentage of users feedback in the form of clinical questionnaire to assess the 'easiness' of insertion procedure with questionnaire
evaluating feed back
Measured: 1 day
Duration of PDT insertion and explantation procedure
monitoring usability needs
Measured: 15 days
Incidence of side effects in Post explantation follow-up
follow up for sequel
Measured: 30 days
Rate of GI dysfunction after 10 days post explantation of the PDT sensor. Follow-up via phone call after 30 days
monitoring of GI symptoms
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start18 Feb 2024
- Primary completion16 Jul 2024 (estimated)
- Study completion20 Sep 2025 (estimated)
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 Intra-Abdominal HypertensionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dotspace Inc.
- Responsible party
- Principal investigator, Dong-Ru Ho, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333366
- Sponsor's protocol ID
- 202301590A0C501
- Other IDs
- Application No.2402020052
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liao CH, Cheng CT, Chen CC, Wang YH, Chiu HT, Peng CC, Jow UM, Lai YL, Chen YC, Ho DR. Systematic Review of Diagnostic Sensors for Intra-Abdominal Pressure Monitoring. Sensors (Basel). 2021 Jul 15;21(14):4824. doi: 10.3390/s21144824.
PubMed 34300564Liao CH, Cheng CT, Chen CC, Jow UM, Chen CH, Lai YL, Chen YC, Ho DR. An Ingestible Electronics for Continuous and Real-Time Intraabdominal Pressure Monitoring. J Pers Med. 2020 Dec 24;11(1):12. doi: 10.3390/jpm11010012.
PubMed 33374271
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-gastrointestinal Monitoring Device (PDT) to Detect Intra-Abdominal Hypertension (IAH): First-In-Human Study of Feasibility and Safety
- ClinicalTrials.gov ID
- NCT06333366
- Acronym / sponsor ID
- 202301590A0C501
- Conditions
- Intra-Abdominal Hypertension
- Keywords
- Intra-Abdominal hypertension, Intravesical pressure, Intra-gastrointestinal monitoring device, laparoscopic surgery, Abdominal compartment Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Dotspace Inc.
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 16 Jul 2024 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 27 Mar 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.
PDT is a continuous pressure monitoring for Intra-Abdominal hypertension (IAH) designed to be less invasive than pan-endoscopic evaluation, more tolerable than abdominal tapping, and more effective than intravesical pressure measurement for IAH. The PDT device consists of a piezoelectric sensor module with a low power Bluetooth wireless transmitter encased in biocompatible capsule. The device will be swallowed after activation. Following PDT insertion, the patient is fitted with a custom, removable external waist accessory containing a receiver, which is worn during monitoring and provide PDT location by signal analysis with sufficient information to provide IAH trends.
Detailed description
The participant will receive first phantom capsule after complete survey before the test, which include standard clinical intra-vesical pressure measurement in the perioperative period of laparoscopic surgery. The phantom capsule is an equal-weighted device of the same outer shell but without the electric circuits. After the phantom capsule has been passed out, the participant will receive the standard PDT capsule to record measured information continuously. The date of the laparoscopic surgery should be within follow-up day 2 to day 6. Standard clinical intra-vesical pressure measurement will only be applied in the perioperative period of laparoscopic surgery. The participant will still be monitored by standard PDT capsule afterwards. After the PDT capsule passed out, the participant will receive complete checkup again for comparison.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intraabdominal pressure (IAP) monitor | Experimental | Device: Intra-gastrointestinal monitoring device (PDT)Patient who will take laparoscopic surgery will be checked for intra-abdominal pressure, intra-vesical pressure, and intra-gastrointestinal pressure ri-operative stage. PDT passage time will be checked. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patient volunteer planning for laparoscopic surgery
- Subjects willing to sign an informed consent form (ICF),
- Adult subjects, age ≥ 20 and age ≤ 80 years old
- BMI between 15（kg/m2）- 35（kg/m2）
- Subjects willing to comply to study protocol requirements (blood pressure measurement, diet, alcohol, study visits, blood sampling, etc.)
Key exclusion criteria (19 listed)
- Patients with a high risk for capsule retention (such as intestinal diverticula, acute abdominal pain without regular defecation indicating intestinal obstruction or a history of abdominal operation or intestinal reconstructed operation),
- Any evidence that occlusion of gastrointestinal tract is obvious or severe paralytic ileus that may result in intra-abdominal hypertension in need of immediate surgical intervention not caused by base of tongue (i.e., central apnea, neurologic disorder, retropalatal collapse, nasal obstruction)
- Any condition that subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- Any factor that, in the surgeon's judgment, would pose a risk to surgery or placement of an intra-gastrointestinal monitoring device
- Any factor that, in the surgeon's judgment, would make the subject unlikely to respond to PDT insertion and pressure measurement.
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 |
|---|---|---|
| Intra-gastrointestinal monitoring device (PDT)The PressureDOT(PDT) is an active intra-gastrointestinal device, that is intended to be introduced in the gastrointestinal tract, approximately along whole. The device is battery powered. The signal is wirelessly transmitted through outside the body and received by waist receiver, using an antenna array applied to the skin with a protection guard at the level of the abdomen. | Device | intraabdominal pressure (IAP) monitor |
Primary outcome
Incidence of device-related or sensor insertion/removal procedure-related adverse events
Time frame: 15 days
evaluating of incidence of adverse event (AE)
Rate of foreign body reaction due intra-gastrointestinal insertion
Time frame: 15 days
evaluating GI symptoms
Rate of GI symptoms, i.e. inflammation, infection, diarrhea, bowel obstruction, and ileus
Time frame: 15 days
evaluating safety
Incidence of sensor failure
Time frame: 15 days
evaluating stability of device
4 secondary outcomes
Percentage of users feedback in the form of clinical questionnaire to assess the 'easiness' of insertion procedure with questionnaire
Time frame: 1 day
Duration of PDT insertion and explantation procedure
Time frame: 15 days
Incidence of side effects in Post explantation follow-up
Time frame: 30 days
Rate of GI dysfunction after 10 days post explantation of the PDT sensor. Follow-up via phone call after 30 days
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Background: PubMed 34300564Liao CH, Cheng CT, Chen CC, Wang YH, Chiu HT, Peng CC, Jow UM, Lai YL, Chen YC, Ho DR. Systematic Review of Diagnostic Sensors for Intra-Abdominal Pressure Monitoring. Sensors (Basel). 2021 Jul 15;21(14):4824. doi: 10.3390/s21144824.
- Results publication: PubMed 33374271Liao CH, Cheng CT, Chen CC, Jow UM, Chen CH, Lai YL, Chen YC, Ho DR. An Ingestible Electronics for Continuous and Real-Time Intraabdominal Pressure Monitoring. J Pers Med. 2020 Dec 24;11(1):12. doi: 10.3390/jpm11010012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-gastrointestinal monitoring device (PDT) in people with Intra-Abdominal Hypertension, run by Chang Gung Memorial 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 7 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 27 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong-Ru Ho, MD, PhD (886-975353211, redoxdrh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of device-related or sensor insertion/removal procedure-related adverse events (time frame: 15 days). The study lists 4 primary outcomes in all. 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 NCT06333366, 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 27 Mar 2024.