First-In-Human Study of PDT to Detect IAH
Intra-gastrointestinal Monitoring Device (PDT) to Detect Intra-Abdominal Hypertension (IAH): First-In-Human Study of Feasibility and Safety
Chang Gung Memorial Hospital
10 participants
Feb 18, 2024
INTERVENTIONAL
Conditions
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. 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.
Eligibility
Inclusion Criteria7
- 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
Exclusion Criteria18
- 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
- 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
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06333366