New device for monitoring intra-abdominal pressure during surgery

Intra-gastrointestinal Monitoring Device (PDT) to Detect Intra-Abdominal Hypertension (IAH): First-In-Human Study of Feasibility and Safety

This study is testing a new device that patients swallow to help doctors monitor pressure in the abdomen during laparoscopic surgery to see if it can improve care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 20 Years to 55 Years
• Sex: All
• Sponsor: Chang Gung Memorial Hospital (Academic / other)
• Locations: 1 site (Chiayi City)
• Trial ID: NCT06333366 on ClinicalTrials.gov

What this trial studies

This study evaluates a novel device designed for continuous monitoring of intra-abdominal hypertension (IAH) during laparoscopic surgery. The device, which is swallowed by the patient, uses a piezoelectric sensor and Bluetooth technology to provide real-time data on intra-abdominal pressure. Participants will first receive a phantom capsule for initial assessment, followed by the active monitoring capsule to track pressure trends post-surgery. The goal is to improve the detection and management of IAH in a less invasive manner compared to traditional methods.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 80 who are scheduled for laparoscopic surgery and meet specific health criteria.

Not a fit: Patients with a high risk of capsule retention or gastrointestinal obstruction may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could lead to better management of intra-abdominal hypertension, improving surgical outcomes and patient safety.

How similar studies have performed: While similar monitoring approaches have been explored, this specific device and method represent a novel approach in the field.

Eligibility criteria

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

Where this trial is running

Chiayi City

• Dong-Ru Ho — Chiayi City, Taiwan (Recruiting)

Study contacts

• Study coordinator: Dong-Ru Ho, MD, PhD

Conditions Intra-Abdominal Hypertension; Intra-Abdominal hypertension; Intravesical pressure; Intra-gastrointestinal monitoring device; laparoscopic surgery; Abdominal compartment Syndrome