Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-24 @ 4:03 PM
NCT ID:
NCT06333366
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT06333366
Study Brief:
Protocol Section:
NCT06333366