The Zenflow Spring System Safety, Performance and Effectiveness Study (ZEST2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03595735|
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : October 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Device: Zenflow Spring System||Not Applicable|
A multi-center, prospective, single arm safety, performance, and effectiveness trial. The study will be conducted in two stages. Upon the successful completion of stage 1, the study will be expanded and continue to stage 2.
Stage 1 will enroll subjects in the Intent to Treat (ITT) cohort. The purpose of stage 1 is to assess acute safety and performance of the Zenflow System at the time of the procedure, through discharge, 2 weeks and 1 month, in up to 10 subjects enrolled at up to 7 investigational sites, to determine continuation to stage 2.
Upon successful completion of stage 1, the study will be expanded to stage 2 with sites added and continued enrollment in the ITT cohort. All subjects, including those enrolled in the stage 1 evaluation, will continue to be followed at all the designated follow-up time points for the full duration of the study (24 months).
Whether or not the study continues to Stage 2, all enrolled subjects will be followed for the entire duration of the study (24 months), or until exited.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Multi-center, prospective, single-arm.|
|Masking:||None (Open Label)|
|Official Title:||The Zenflow Spring System Safety, Performance and Effectiveness Study (ZEST2)|
|Actual Study Start Date :||June 21, 2018|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||March 30, 2021|
Experimental: Treatment Group
Receives treatment with the Zenflow Spring System
Device: Zenflow Spring System
The Zenflow Spring System consists of the Spring Delivery System with Implant, Spring Scope, Camera Control Unit (CCU), Measurement Tool, and Spring Retrieval Tool.
Other Name: Spring Implant
- Successful placement of the Zenflow Spring Implant [ Time Frame: Day of discharge up to 7 days following device placement ]Successful deployment and procedural success for the Zenflow System to implant the Spring device in the operating room or an out-patient clinical setting.
- Need for urinary catheterization [ Time Frame: 7 days after the procedure ]Rate of extended post-operative urinary catheterization
- Incidence of procedure or device related serious adverse events [ Time Frame: Day of discharge up to 7 days following device placement ]Assessment of any device or procedure related Serious Adverse Events (SAE)
- Assessment of Pain [ Time Frame: Baseline, 2 weeks, 1 month and 3 months ]Patient describes pain on a Visual Analog Scale (VAS). The scale is a line labeled 1 at the far left indicating minimal pain and 10 on the right, which is maximum pain.
- Assessment of Adverse Events [ Time Frame: Up to 2 years ]Rate of adverse events related to the procedure or device.
- Assessment of Sexual Health: Change in sexual health measured by change in the Sexual Health Inventory for Men (SHIM) questionnaire score [ Time Frame: Baseline, 3, 6, 12, & 24 months ]The patient selects the most appropriate response to 5 questions about his sexual health. Each response has an assigned value between 1 and 5. The numeric values are tallied for a total score.
- Assessment of Sexual Health: Change in sexual health measured by change in ability to ejaculate using the Male Sexual Health Questionnaire - Ejaculatory domain (MSHQ-EjD) [ Time Frame: Baseline, 3, 6, 12, & 24 months ]The patient selects the most appropriate response to 4 questions about his sexual health specific to ejaculation. Each response has an assigned value between 0 and 5.
- Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) by patient response to the International Prostate Symptom Score and Quality of Life Questionnaire (IPSS+QoL). [ Time Frame: Baseline, 2 weeks, 1, 6, 12, 24 months ]The patient is asked to respond to 7 questions related to his urinary health using a rating scale of 0 to 5 where is zero is excellent and 5 is the worst possible. The responses to the 7 questions are tallied for a total score. In addition the patient is asked 1 question related to his Quality of Life. The possible responses range from 0 to 6 where 0 is the best and 6 is the worst.
- Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) [ Time Frame: Baseline, 2 weeks, 1, 3, 6, 12, 24 months ]Improvement in flow of urine
- Repeat interventions to treat Benign Prostatic Hyperplasia (BPH) [ Time Frame: Up to 2 years ]Incidence of repeat invasive treatment for Lower Urinary Tract Symptoms (LUTS) or increase in dosage or initiation of new medication to treat symptoms of BPH.
- Increase or change in medications to treat Benign Prostatic Hyperplasia (BPH) [ Time Frame: Up to 2 years ]Incidence of increase in dosage, or initiation of new medication to treat symptoms of BPH.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595735
|Contact: Debra Cogan, B.A., R.N.||+001 408 email@example.com|
|Contact: Nicholas Damiano, MS||+001 650 642-9658||Nick@zenflow.com|
|Hospital Regional de Alta Especialidad de Ixtapaluca||Not yet recruiting|
|Zoquiapan, Ciudad de Ixtapaluca, Mexico, 56530|
|Contact: Rodrigo Becerra Perez, MD + (52 55) 5972 9800 firstname.lastname@example.org|
|Contact: Melanie Racette, RN 5215528551962 email@example.com|
|Hospital Universitario "Dr. José Eleuterio González"||Recruiting|
|Monterrey, Nuevo León, Mexico, 64460|
|Contact: Lauro Gomez, MD +(52 81) 8333 1713 ext 3136 firstname.lastname@example.org|
|Centro de Urología Avanzada del Noreste (CUAN)||Recruiting|
|Monterrey, Nuevo León, Mexico, 66269|
|Contact: Juan J Galan, MD +(52 81) 8363 1717 email@example.com|
|Contact: Antonia Salazar, RN +(52 81) 8363 1717 firstname.lastname@example.org|
|Principal Investigator:||Juan J Galan, MD||Centro de Urología Avanzada del Noreste (CUAN)|