Intra-Abdominal Hypertension Clinical Trial
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | September 20, 2025 |
Est. primary completion date | July 16, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 55 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Dong-Ru Ho | Chiayi City |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital | DOTSPACE |
Taiwan,
Liao 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rate of sensor ability to measure intra-gastrointestinal pressure (IGP) to allow the development of the algorithm | workup for correlation | 5 days | |
Other | Incidence of influence of interference substances (i.e. water, saliva, gastric juice, bile, intestinal secretion, feces, and food debris ) | evaluating feasibility of working condition | 7 days | |
Primary | Incidence of device-related or sensor insertion/removal procedure-related adverse events | evaluating of incidence of adverse event (AE) | 15 days | |
Primary | Rate of foreign body reaction due intra-gastrointestinal insertion | evaluating GI symptoms | 15 days | |
Primary | Rate of GI symptoms, i.e. inflammation, infection, diarrhea, bowel obstruction, and ileus | evaluating safety | 15 days | |
Primary | Incidence of sensor failure | evaluating stability of device | 15 days | |
Secondary | Percentage of users feedback in the form of clinical questionnaire to assess the 'easiness' of insertion procedure with questionnaire | evaluating feed back | 1 day | |
Secondary | Duration of PDT insertion and explantation procedure | monitoring usability needs | 15 days | |
Secondary | Incidence of side effects in Post explantation follow-up | follow up for sequel | 30 days | |
Secondary | 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 | 30 days |
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