Temperature Mapping of the Prostate With the Wallterm™ System

Benign Prostatic Hyperplasia Clinical Trial

— WT-DK-TMW08  

Official title:

Temperature Mapping of the Prostate With the Wallterm™ System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662350
• Other study ID #: WT-DK-TMW08
• Status: Completed
• Phase: N/A
• First received: April 7, 2008
• Last updated: February 3, 2010
• Start date: June 2008
• Est. completion date: August 2009

Study information

• Verified date: February 2010
• Source: Pnn Medical A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Observational

Clinical Trial Summary

To measure intra-prostatic temperatures and evaluate the shape and size of necrotic lesions achieved under the standard treatment protocol in men with benign prostatic hyperplasia (BPH).

Description:

The Wallterm System provides minimally invasive treatment of benign prostatic hyperplasia (BPH) via a high temperature, liquid filled, balloon thermotherapy. The catheter is composed of a silicone positioning balloon which anchors the catheter against the bladder neck. The multi-layer silicone treatment balloon may be adjusted to fit short (20-35mm) and long (40-55mm) prostates and is inflated (to approximately 650-700 mmHg / 20-22mm diameter) to ensure tight tissue contact and reduced blood perfusion. The handle contains the heating element and the liquid circulation mechanisms

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Men with symptomatic BPH requiring treatment,

• IPSS score > 15

• Age > 50 years

• Prostate size of 25 g or greater

• Prostatic urethra length between 2.0 cm and 5.5 cm,

• Ability to understand and consent to participate in this investigation,

• Willingness and ability to participate in all required follow-up evaluations.

Exclusion Criteria:

• Allergy towards Silicone,

• Peak Urinary Flow > 15 mL/s,

• Penile or urinary sphincter implant,

• Patients with active urinary tract infection indicated by a positive urinary culture >105 CFU (Note: These patients may be treated after successful treatment of the infection.)

• Clinical (historical), paraclinical (i.e. PSA> 10ng/mL) or histological evidence of prostatic cancer or bladder cancer,

• Evidence of a non-symmetric prostatic median lobe enlargement, or a prostatic lobe which is prominent with an obstructing "ball valve", as determined by cystoscopy or ultrasound,

• Patients with any previous prostate surgery, procedure for BPH, or any other invasive treatment to the prostate (such as TUR-P).

• Previous rectal surgery (Exception: hemorrhoid surgery), radical pelvic surgery or pelvic irradiation.

• Patients with confirmed or suspected bladder cancer.

• Patients with a history of cystolithiasis or bladder pathology, or who have experienced relapsing bacterial prostatitis within the last 6 months.

• Patients with gross haematuria. (Note: These patients may be eligible for this investigation if the results of a careful workup for cancer, including an X-ray study, cystoscopy and cytology, are found to be negative.)

• Patients with a history of bladder neck contracture.

• Patients who presently have urethral strictures, which prevent the passage of a 20 Fr endoscope (these patients may be treated after successful treatment of the stricture).

• Patients with neurogenic bladder dysfunction (neurogenic detrusor hypo- or hyperactivity).

• Patients interested in future fertility.

• Patients who have chronic catheter drainage due to urinary retention (these patients may be treated if a CMG demonstrates that the patient has a contractile bladder).

• Patients with bleeding disorders, or other systemic disorder contraindication minimally invasive surgical therapies.

• Any condition (ie: vascular clips) which would preclude an MRI from being performed, or otherwise confound this investigation.

• Patients with compromised renal function (i.e. serum creatinine >150 mls/l), renal or upper tract dilatation.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• The Wallterm™ System
The Wallterm™ System is intended to ablate prostatic glandular and stromal tissue to relieve moderate to severe symptoms of outflow obstruction secondary to benign prostatic hyperplasia (BPH).

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Pnn Medical A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the temperatures within the prostate using the Wallterm System		Assessed at primary treatment	Yes
Secondary	To assess whether the Wallterm System delivers safe and consistent temperatures from base to apex; and determine the temperature range toward rectum, along the urethra.		Immediate	Yes
Secondary	Delineate the extent and the location of necrosis		Short term	No