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A dual-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis with catheters along with the use or absence of a hemostatic agent following treatment with the AQUABEAM System.
PROCEPT BioRobotics has developed the AQUABEAM, a personalized image-guided waterjet resection system that utilizes a high-pressure saline stream to resect and remove prostate tissue in males suffering from LUTS due to BPH. The primary objective of this study is to evaluate the safety and performance of obtaining hemostasis using balloon catheters with and without hemostatic agents following prostate resection using AQUABEAM for the treatment of LUTS resulting from BPH. Up to 50 participants will be included in the trial at one clinical study site. All patients will be followed up for 3 months for safety assessment prior to study exit. The trial is a dual-arm prospective, interventional clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter without Hemostatic Agent Following Aquablation | Experimental | AQUABEAM System followed by catheter without hemostatic agent |
|
| Catheter with Hemostatic Agent Following Aquablation | Experimental | AQUABEAM System followed by catheter with hemostatic agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AQUABEAM System followed by catheter without hemostatic agent | Device | The AquaBeam system delivers a high-pressure saline stream under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. The physician uses ultrasound imaging to plan the treatment contour and depth to define the treatment region. The physician will use balloon catheter to achieve hemostasis post-Aquablation procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects that do not require a transfusion and do not return to the operating room for hematuria management within 7 days following the index procedure. | Adequate hemostasis post-Aquablation with the use of a urinary catheter and / or delivery of a hemostatic agent, measured by the number of subjects that, within 7 days following the index procedure, do not require a transfusion and do not return to the operating room for hematuria management. | 7 days post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muljibhai Patel Urological Hospital | Nadiād | Gujarat | 387001 | India |
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|
| AQUABEAM System followed by catheter with hemostatic agent | Device | The AquaBeam system delivers a high-pressure saline stream under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. The physician uses ultrasound imaging to plan the treatment contour and depth to define the treatment region. The physician will use balloon catheter with hemostatic agent to achieve hemostasis post-Aquablation procedure. |
|
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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