NCT00662350

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

February 4, 2010

Status Verified

February 1, 2010

Enrollment Period

1.1 years

First QC Date

April 7, 2008

Last Update Submit

February 3, 2010

Conditions

Benign Prostatic Hyperplasia

Keywords

BPH

Outcome Measures

Primary Outcomes (1)

  • To assess the temperatures within the prostate using the Wallterm System

    Assessed at primary treatment

Secondary Outcomes (2)

  • 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

  • Delineate the extent and the location of necrosis

    Short term

Study Arms (1)

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

Interventions

The Wallterm™ SystemDEVICE

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).

Also known as: Wallterm™ Catheter (model 3010), Wallterm™ Central Unit (model 3020-10)
Symptomatic Benign Protate Hypertrophy

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men with BPH

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Jørgen Nordling, Professor

    Urological Dep., Herlev Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 7, 2008

First Posted

April 21, 2008

Study Start

June 1, 2008

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

February 4, 2010

Record last verified: 2010-02

Locations

DK(1)