Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia

• Sponsor: Medi-Tate Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01436877
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arm: 1
• Duration (Months): 60
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and efficacy of MediTate Temporary Implantable Nitinol Device (TIND) used to alleviate symptoms of Bladder Outlet Obstruction (BOO) secondary to Benign Prostate Hyperplasia (BPH).The TIND is inserted in the bladder neck and prostatic urethra under local anesthesia for few days and taken out some 5 days later in the doctors office.

Condition or Disease	Intervention/Treatment	Phase
Bladder Neck Obstruction; Benign Prostate Hyperplasia	Device: Insertion of Temporary Implantable Nitinol Device (TIND)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: One-arm Feasibility and Prospective Pivotal Study to Assess the Safety and Efficacy of MediTate Temporary Implantable Nitinol Device (TIND) in Subjects Presenting Bladder Outlet Obstruction Secondary to BPH
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: device Insertion of Temporary Implantable Nitinol Device (TIND)	Device: Insertion of Temporary Implantable Nitinol Device (TIND); Subjects will be inserted with the Temporary Implantable Nitinol Device (TIND) to the bladder neck and urethral prostate for 5 days and thereafter the TIND will be withdrawn in the doctor office.

Outcome Measures

Primary Outcome Measures

1. Device related and unanticipated SAE [At 3 months]

   Device related and unanticipated SAEs will be followed. No such SAEs are expected.

Secondary Outcome Measures

1. Reduce at least 3 point in the International Prostate Symptom Score (IPSS) in at least 75% of subjects [At 3 months]

   Questionnaire of IPSS will be done in each visit.

2. Increase of maximal urinary peak flow by at least 3 ml/s in at least 75% of subjects [At 3 months]

   Maximal uroflow will be measured in each visit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 95 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Main IC:

• Subject signed informed consent prior to the performance of any study procedures.

• Male with BPH, who are at least 50 years of age and that were diagnosed with BOO.

• IPSS symptom severity score ≥ 10.

• Peak urinary flow of < 12 ml/sec

• No pathology found with kidney US

• Prostatic urethra length < 30 mm

• Prostate volume < 35 cc

• Normal Urinalysis and urine culture.

Exclusion Criteria:

Main EC:

• Any prior prostate treatment

• Suspected or proved carcinoma of prostate

• Urethral stricture

• Urinary bladder stones

• Serum prostate specific antigen level > 4 ng/ml (unless proved to be carcinoma free by biopsy).

• Active urinary tract infection as determined by positive culture, bacterial prostatitis within the past year documented by positive culture.

• Median prostatic lobe enlargement or a prominent obstructing "ball valve" prostatic lobe.

• Subject has an interest in future fertility and is not willing to undergo fertility treatments whatsoever.

• Any serious medical condition likely to impede successful completion of the study

Intraoperative EC:

• Irregular findings by the implanting physician during the implantation procedure by the cystoscopy that to the best of the implanting physician are exerting non compliance with the exclusion or inclusion criteria and that were not noticed previously during screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meir Medical center	Kfar Saba		Israel

Sponsors and Collaborators

• Medi-Tate Ltd.

Investigators

• Principal Investigator: Roy Farfara, MD, Bnai Zion Medical Center, Haifa, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medi-Tate Ltd.
• ClinicalTrials.gov Identifier: NCT01436877
• Other Study ID Numbers: MT-01
• First Posted: Sep 20, 2011
• Last Update Posted: Dec 21, 2018
• Last Verified: Dec 1, 2018

• Keywords provided by Medi-Tate Ltd.: BPH; bladder neck obstruction; Bladder neck obstruction secondary to BPH
• Additional relevant MeSH terms: Prostatic Hyperplasia; Urinary Bladder Neck Obstruction; Hyperplasia

Study Results

No Results Posted as of Dec 21, 2018