Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-01-10 @ 4:43 AM
Study NCT ID:
NCT00662350
Status:
COMPLETED
Last Update Posted:
2010-02-04
First Post:
2008-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Temperature Mapping of the Prostate With the Wallterm™ System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-03', 'studyFirstSubmitDate': '2008-04-07', 'studyFirstSubmitQcDate': '2008-04-17', 'lastUpdatePostDateStruct': {'date': '2010-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the temperatures within the prostate using the Wallterm System', 'timeFrame': 'Assessed at primary treatment'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': 'Immediate'}, {'measure': 'Delineate the extent and the location of necrosis', 'timeFrame': 'Short term'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BPH'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men with BPH', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men with symptomatic BPH requiring treatment,\n* IPSS score \\> 15\n* Age \\> 50 years\n* Prostate size of 25 g or greater\n* Prostatic urethra length between 2.0 cm and 5.5 cm,\n* Ability to understand and consent to participate in this investigation,\n* Willingness and ability to participate in all required follow-up evaluations.\n\nExclusion Criteria:\n\n* Allergy towards Silicone,\n* Peak Urinary Flow \\> 15 mL/s,\n* Penile or urinary sphincter implant,\n* 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.)\n* Clinical (historical), paraclinical (i.e. PSA\\> 10ng/mL) or histological evidence of prostatic cancer or bladder cancer,\n* 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,\n* Patients with any previous prostate surgery, procedure for BPH, or any other invasive treatment to the prostate (such as TUR-P).\n* Previous rectal surgery (Exception: hemorrhoid surgery), radical pelvic surgery or pelvic irradiation.\n* Patients with confirmed or suspected bladder cancer.\n* Patients with a history of cystolithiasis or bladder pathology, or who have experienced relapsing bacterial prostatitis within the last 6 months.\n* 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.)\n* Patients with a history of bladder neck contracture.\n* 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).\n* Patients with neurogenic bladder dysfunction (neurogenic detrusor hypo- or hyperactivity).\n* Patients interested in future fertility.\n* 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).\n* Patients with bleeding disorders, or other systemic disorder contraindication minimally invasive surgical therapies.\n* Any condition (ie: vascular clips) which would preclude an MRI from being performed, or otherwise confound this investigation.\n* Patients with compromised renal function (i.e. serum creatinine \\>150 mls/l), renal or upper tract dilatation.'}, 'identificationModule': {'nctId': 'NCT00662350', 'acronym': 'WT-DK-TMW08', 'briefTitle': 'Temperature Mapping of the Prostate With the Wallterm™ System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pnn Medical A/S'}, 'officialTitle': 'Temperature Mapping of the Prostate With the Wallterm™ System', 'orgStudyIdInfo': {'id': 'WT-DK-TMW08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Symptomatic Benign Protate Hypertrophy', 'description': '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', 'interventionNames': ['Device: The Wallterm™ System']}], 'interventions': [{'name': 'The Wallterm™ System', 'type': 'DEVICE', 'otherNames': ['Wallterm™ Catheter (model 3010)', 'Wallterm™ Central Unit (model 3020-10)'], 'description': '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).', 'armGroupLabels': ['Symptomatic Benign Protate Hypertrophy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Jørgen Nordling, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urological Dep., Herlev Hospital, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pnn Medical A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jacob Hyllested-Winge, M.D., VP, Director Clinical And Regulatory', 'oldOrganization': 'Pnn Medical'}}}}