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

Benign Prostate Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436877
• Other study ID #: MT-01
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: September 2016

Study information

• Verified date: December 2018
• Source: Medi-Tate Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Bladder Neck Obstruction
• Hyperplasia
• Prostatic Hyperplasia
• Urinary Bladder Neck Obstruction

Intervention

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.

Locations

Country	Name	City	State
Israel	Meir Medical center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Medi-Tate Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device related and unanticipated SAE	Device related and unanticipated SAEs will be followed. No such SAEs are expected.	At 3 months
Secondary	Reduce at least 3 point in the International Prostate Symptom Score (IPSS) in at least 75% of subjects	Questionnaire of IPSS will be done in each visit.	At 3 months
Secondary	Increase of maximal urinary peak flow by at least 3 ml/s in at least 75% of subjects	Maximal uroflow will be measured in each visit	At 3 months