Temperature Mapping of the Prostate With the Wallterm™ System (WT-DK-TMW08)

This study has been completed.
Sponsor:
Information provided by:
Pnn Medical A/S
ClinicalTrials.gov Identifier:
NCT00662350
First received: April 7, 2008
Last updated: February 3, 2010
Last verified: February 2010
  Purpose

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).


Condition Intervention
Benign Prostatic Hyperplasia
Device: The Wallterm™ System

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Temperature Mapping of the Prostate With the Wallterm™ System

Resource links provided by NLM:


Further study details as provided by Pnn Medical A/S:

Primary Outcome Measures:
  • To assess the temperatures within the prostate using the Wallterm System [ Time Frame: Assessed at primary treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]
  • Delineate the extent and the location of necrosis [ Time Frame: Short term ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Symptomatic Benign Protate Hypertrophy
Symptom Score (IPSS) greater than 15, requiring invasive treatment, Prostate size greater than 25 g, Prostatic urethra length between 2.0 cm and 5.5 cm
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).
Other Names:
  • Wallterm™ Catheter (model 3010)
  • Wallterm™ Central Unit (model 3020-10)

Detailed 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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Men with BPH

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662350

Locations
Denmark
Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Pnn Medical A/S
Investigators
Principal Investigator: Jørgen Nordling, Professor Urological Dep., Herlev Hospital, Denmark
  More Information

No publications provided

Responsible Party: Jacob Hyllested-Winge, M.D., VP, Director Clinical And Regulatory, Pnn Medical
ClinicalTrials.gov Identifier: NCT00662350     History of Changes
Other Study ID Numbers: WT-DK-TMW08
Study First Received: April 7, 2008
Last Updated: February 3, 2010
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by Pnn Medical A/S:
BPH

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014