An interventional study of Intra-gastrointestinal monitoring device (PDT) in Intra-Abdominal Hypertension, sponsored by Chang Gung Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-03-27.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
61 studies on the registry are indexed under Intra-Abdominal Hypertension; 12 are open to participants now.
This study's planned enrollment of 10 is below the median of 60 across 29 interventional studies indexed under Intra-Abdominal Hypertension.
Browse Intra-Abdominal Hypertension studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: 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.
Incidence of device-related or sensor insertion/removal procedure-related adverse events
evaluating of incidence of adverse event (AE)
Time frame: 15 days
Rate of foreign body reaction due intra-gastrointestinal insertion
evaluating GI symptoms
Time frame: 15 days
Rate of GI symptoms, i.e. inflammation, infection, diarrhea, bowel obstruction, and ileus
evaluating safety
Time frame: 15 days
Incidence of sensor failure
evaluating stability of device
Time frame: 15 days
Percentage of users feedback in the form of clinical questionnaire to assess the 'easiness' of insertion procedure with questionnaire
evaluating feed back
Time frame: 1 day
Duration of PDT insertion and explantation procedure
monitoring usability needs
Time frame: 15 days
Incidence of side effects in Post explantation follow-up
follow up for sequel
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
monitoring of GI symptoms
Time frame: 30 days
Rate of sensor ability to measure intra-gastrointestinal pressure (IGP) to allow the development of the algorithm
workup for correlation
Time frame: 5 days
Incidence of influence of interference substances (i.e. water, saliva, gastric juice, bile, intestinal secretion, feces, and food debris )
evaluating feasibility of working condition
Time frame: 7 days
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