Study to Assess the Efficacy of Medi-Tate iTind Device

Benign Prostatic Hyperplasia (BPH) Clinical Trial

Official title:

One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-Tate Temporary Implantable Nitinol Device (iTindTM) in Subjects With Benign Prostatic Hypertrophy (BPH).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145208
• Other study ID #: MT-02
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: November 2021

Study information

• Verified date: April 2022
• Source: Medi-Tate Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will include an implantation of the iTind device and 4 follow up visits up to 12 months after the implantation.

Description:

After screening , eligible patients will undergo an an implantation procedure (operative), using the iTind device. Implantation will be performed according to the Instructions For Use. Between the 5th - 7th days, the iTind will be retrieved through a rigid cystoscope sheath, under direct vision. Before retrieval the subject will be asked for subjective discomfort evaluation and level of urgency in the past days after device insertion, about any AE and then the device will be retrieved. The next visits will be at 4 weeks (post device retrieval), 3 months, 6 months, and 12 months post implantation with an optional extension of follow up period (up to 36 months). In the visits the following will be assessed: Uroflow and residual urine volume tests, AE recording, IPSS, and Questions on sex performing capability and ejaculation filled out by the subjects, in the local languages.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: November 2021
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subject signed informed consent prior to the performance of any study procedures.
• Male with symptomatic BPH. IPSS symptom severity score above 10. Peak urinary flow of below 12 ml/sec
• Prostate volume below 75 ml
• Blood CBC and biochemistry up to two weeks before screening demonstrating: Normal values of the PT, PTT and INR tests (anticoagulants should be stopped according to GCP)
• Subject that able to complete the study protocol.
• Normal Urinalysis and urine culture

Exclusion Criteria:

• cardiac arrhythmias, cardiac disease including congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression;
• neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.;
• a post void residual (PVR) volume above 250 ml measured by ultrasound or acute urinary retention
• compromised renal function (i.e., serum creatinine level above 1.8 mg/dl, or upper tract disease);
• confirmed or suspected bladder cancer;
• recent (within 3 months) cystolithiasis or hematuria;
• urethral strictures, bladder neck contracture, Urinary bladder stones
• or other potentially confounding bladder pathology;
• an active urinary tract infection.
• Enrolled in another treatment trial for any disease within the past 30 days.
• previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy may potentially cause injury to sites of previous rectal surgery, e.g., if a transrectal probe is used;
• previous pelvic irradiation or radical pelvic surgery;
• previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
• Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years).
• 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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• TIND System
An implant

Locations

Country	Name	City	State
Belgium	Edith Cavell	Brussels
Belgium	Gent Hospital University	Gent
Italy	San Orbessano	Turin
Spain	La Paz Hospital	Madrid
Switzerland	Kantonsspital Frauenfeld	Frauenfeld
Switzerland	Lausanne University Hospital	Lausanne
United Kingdom	Frimley Health NHS	London
United Kingdom	University College Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Medi-Tate Ltd.

Countries where clinical trial is conducted

Belgium,  Italy,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IPSS	Change of IPSS score by at least 3 points, in at least 75 % of the subjects, at 6 months follow-up.; IPSS - The International Prostate Symptom Score. Scale: minimum 0 (zero), maximum 35. Lower values are better.	6 months.
Primary	SAE	The incidence of unexpected serious adverse events related to Meditate iTind and/or implantation/retrieval procedures, as determined by the investigator and the study medical monitor.	5-7 days
Secondary	Urinary peak flow	Increase of maximal urinary peak flow	12 months