protocolSection identificationModule nctId: NCT06333366, orgStudyIdInfo id: 202301590A0C501, secondaryIdInfos id: Application No.2402020052, type: OTHER, domain: Chang Gung Memorial Hospital, briefTitle: First-In-Human Study of PDT to Detect IAH, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-18, primaryCompletionDateStruct date: 2024-07-16, completionDateStruct date: 2025-09-20, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, collaborators name: DOTSPACE, descriptionModule briefSummary: 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., conditionsModule conditions: Intra-Abdominal Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Intra-gastrointestinal monitoring device (PDT), outcomesModule primaryOutcomes measure: Incidence of device-related or sensor insertion/removal procedure-related adverse events, primaryOutcomes measure: Rate of foreign body reaction due intra-gastrointestinal insertion, primaryOutcomes measure: Rate of GI symptoms, i.e. inflammation, infection, diarrhea, bowel obstruction, and ileus, primaryOutcomes measure: Incidence of sensor failure, secondaryOutcomes measure: Percentage of users feedback in the form of clinical questionnaire to assess the 'easiness' of insertion procedure with questionnaire, secondaryOutcomes measure: Duration of PDT insertion and explantation procedure, secondaryOutcomes measure: Incidence of side effects in Post explantation follow-up, secondaryOutcomes measure: Rate of GI dysfunction after 10 days post explantation of the PDT sensor. Follow-up via phone call after 30 days, otherOutcomes measure: Rate of sensor ability to measure intra-gastrointestinal pressure (IGP) to allow the development of the algorithm, otherOutcomes measure: Incidence of influence of interference substances (i.e. water, saliva, gastric juice, bile, intestinal secretion, feces, and food debris ), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Dong-Ru Ho, status: RECRUITING, city: Chiayi City, zip: 60061, country: Taiwan, contacts name: Dong-Ru Ho, MD, PhD, role: CONTACT, phone: 886-975353211, email: redoxdrh@gmail.com, contacts role: CONTACT, phoneExt: Ho, email: redoxdrh@gmail.com, contacts name: Dong-Ru Ho, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.47917, lon: 120.44889, hasResults: False