Pivotal Study to Assess the Safety and Effectiveness of the iTind Device

February 16, 2022 updated by: Medi-Tate Ltd.

Multi-center Prospective Study to Assess the Safety and Effectiveness of Medi-Tate i-Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)

The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as compared to control group (catheter only).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Medi-Tate i-Temporary Implantable Nitinol Device (iTind) is intended to treat subjects with symptomatic BPH.

A total of 150 subjects with symptomatic BPH will be enrolled into this study, according to eligibility criteria.

Study duration is 12 months and includes 7 visits: screening, screening follow up, implantation, retrieval, 6 weeks follow up, 3 months follow up and 12 months follow up.

iTind Device will be implanted for 5-7 days. Sham will be a routine Foley catheter procedure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
185

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Toronto, Canada
        • Toronto
    • Quebec
      • Sherbrooke, Quebec, Canada
        • CIUSS de l'Estrie-CHUS
  • United States
    • Florida
      • Pompano Beach, Florida, United States, 33060
        • Clinical Research Center of Florida
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Chesapeake Urology Research Associates
    • New York
      • Brooklyn, New York, United States, 11215
        • Methodist Hospital
      • Garden City, New York, United States, 11501
        • Winthrop University
      • Lawrence, New York, United States, 11691
        • St John's Episcopal
      • Long Island City, New York, United States, 11735
        • Integrated Medical Professionals
      • Manhattan, New York, United States, 10016
        • Manhattan Medical Research
      • Manhattan, New York, United States, 10065
        • Weill Cornell
      • New York, New York, United States, 08857
        • Premier Urology Group
      • Poughkeepsie, New York, United States, 12601
        • Primier Medical Center
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Uro Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Subject signed informed consent form (ICF)
  2. Age 50 and above
  3. Male with symptomatic BPH.
  4. IPSS symptom severity score ≥ 10
  5. Peak urinary flow of < 12 ml/sec . Meeting the criterion on (2) two separate voiding trials , on a minimum voided volume of at least 125 cc for each voiding trial.
  6. Prostate volume between 25 ml to 75 ml (assessed by ultrasound)
  7. 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)
  8. Subject able to comply with the study protocol
  9. Normal Urinalysis and urine culture

Exclusion Criteria:

  1. Cardiac arrhythmias, cardiac disease including congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression;
  2. Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes
  3. A post void residual (PVR) volume > 250 ml measured by ultrasound or acute urinary retention
  4. Compromised renal function (i.e., serum creatinine level > 1.8 mg/dl, or upper tract disease);
  5. Confirmed or suspected bladder cancer;
  6. Recent (within 3 months) cystolithiasis or hematuria;
  7. Urethral strictures, bladder neck contracture, urinary bladder stones or other potentially confounding bladder pathology;
  8. An active urinary tract infection.
  9. Enrolled in another treatment trial for any disease within the past 30 days.
  10. Previous colo- 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;
  11. Previous pelvic irradiation, cryosurgery or radical pelvic surgery;
  12. Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
  13. History of prostatitis within the past 5 years.
  14. Median lobe obstruction of the prostate.
  15. 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).
  16. Any serious medical condition likely to impede successful completion of the study
  17. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
  18. Subjects who are actively taking medications that affects urination and BPH symptoms not completing the required washout period.
  19. Baseline PSA ≥ 10 ng/ml.
  20. Positive DRE.
  21. Baseline PSA between 2.5-10 ng/ml and free PSA < 25%, without a subsequent negative prostate biopsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: iTind arm
iTind implant is implant during the study for 5-7 days.
Device: iTIND
Temporary Implantable Nitinol Device (iTIND)
Sham Comparator: Sham arm
Foley catheter is used during the study
Procedure: Sham Arm
Foley catheter will be placed and immediately removed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Month 3 Results in the IPSS Score in Both Arms.
Time Frame: 3 months
Month 3 results in the IPSS Score in both arms IPSS - The International Prostate Symptom Score. Scale: minimum 0 (zero), maximum 35. Lower values are better.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Qmax Measurement
Time Frame: 3 months
Month 3 results in Qmax (maximum urinary flow rate)
3 months
PVR
Time Frame: 3 months
Month 3 results in PVR (post-void residual urine volume)
3 months
IIEF Questionnaire
Time Frame: 3 months
The International Index of Erectile Function score. Scale: minimum 6, maximum 75. Higher values are better. Month 3 results in IIEF.
3 months
SHIM
Time Frame: 3 months
The Sexual Health Inventory for Men questionnaire. Scale: minimum 1, maximum 25. Higher values are better. Month 3 results in SHIM.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medi-Tate Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sheldon Pike, MD, St. John's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MT-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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