Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Application No.2402020052 | Other Identifier | Chang Gung Memorial Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dotspace Inc. | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intraabdominal pressure (IAP) monitor | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-gastrointestinal monitoring device (PDT) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of device-related or sensor insertion/removal procedure-related adverse events | evaluating of incidence of adverse event (AE) | 15 days |
| Rate of foreign body reaction due intra-gastrointestinal insertion | evaluating GI symptoms | 15 days |
| Rate of GI symptoms, i.e. inflammation, infection, diarrhea, bowel obstruction, and ileus | evaluating safety | 15 days |
| Incidence of sensor failure | evaluating stability of device | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of users feedback in the form of clinical questionnaire to assess the 'easiness' of insertion procedure with questionnaire | evaluating feed back | 1 day |
| Duration of PDT insertion and explantation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of sensor ability to measure intra-gastrointestinal pressure (IGP) to allow the development of the algorithm | workup for correlation | 5 days |
| Incidence of influence of interference substances (i.e. water, saliva, gastric juice, bile, intestinal secretion, feces, and food debris ) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong-Ru Ho, MD, PhD | Contact | 886-975353211 | redoxdrh@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-Ru Ho | Recruiting | Chiayi City | 60061 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34300564 | Background | 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. | |
| 33374271 | Result | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059325 | Intra-Abdominal Hypertension |
| ID | Term |
|---|---|
| D003161 | Compartment Syndromes |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
monitoring usability needs
| 15 days |
| Incidence of side effects in Post explantation follow-up | follow up for sequel | 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 | 30 days |
evaluating feasibility of working condition |
| 7 days |
| D002318 |
| Cardiovascular Diseases |