Plan A -okklaasio- ja kumoamisjärjestelmän toteutettavuustutkimus
Prospektiivinen, monikeskuksinen, yksihaarainen, avoimen leiman interventiokliininen tutkimus Plan A -miespuolisen ehkäisyjärjestelmän turvallisuutta ja tehokkuutta selvittämässä.
Prospective, multicenter, single-arm, open label, interventional clinical trial investigating the safety and effectiveness of the Plan A Male Contraceptive System to occlude the vas deferens to block the passage of sperm and then be reversed to subsequently allow the passage of sperm through the vas deferens.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
Prospective, multicenter, single-arm, open label, interventional clinical trial investigating the safety and effectiveness of the Plan A Male Contraceptive System to occlude the vas deferens to block the passage of sperm and then be reversed to subsequently allow the passage of sperm through the vas deferens. 40 men (all sites) will be enrolled and treated with Plan A occlusion (Vasalgel®) using DLAD (Delivery Lumen Access Device). The study will enroll into two groups. Group 1 will include 30 subjects that will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will be offered a vasectomy procedure. Group 2 will recruit ten subjects who will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will have the reversal procedure using the Plan A RD (Reversal Device). This group will be followed for up to another 3 months maximum, or until baseline semen levels are achieved at which point they will be offered a vasectomy procedure. Ten men reaching azoospermia after their occlusion procedure will be allocated to Group 2 and will go on to have the reversal procedure.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Darlene Walley R Chief Executive Officer, PhD
- Puhelinnumero: 1-415-407-5229
- Sähköposti: darlene.walley@nextlifesciences.org
Opiskelupaikat
-
-
Victoria
-
Maribyrnong, Victoria, Australia, 3032
- Rekrytointi
- Western Urology
-
Ottaa yhteyttä:
- Homi Zargar, MD
- Puhelinnumero: +1 61 300 927 427
- Sähköposti: pa@homizargar.com.au
-
St Kilda, Victoria, Australia, 3182
- Rekrytointi
- Dr. Snip
-
Ottaa yhteyttä:
- Sarah Demediuk, MD
- Puhelinnumero: 1300 377 647
- Sähköposti: sarah@drsnip.au
-
-
-
-
Ontario
-
Hawkesbury, Ontario, Kanada, K6A 1A8
- Ei vielä rekrytointia
- Clinique de Vasectomie
-
Ottaa yhteyttä:
- Jean Philippe-Bercier, MD
- Puhelinnumero: 613-762-0997
- Sähköposti: jeanphilippebercier@gmail.com
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Male subject who is seeking and suitable to undergo a vasectomy as a long-term form of contraception
- Male subject who has voluntarily signed and dated the Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form (ICF) for this study prior to initiation of any screening or study specific procedures
- 25 to 65 years of age at the time of consent
- Body Mass Index (BMI) <31 kg/m2
- Good health for undergoing a vasectomy as confirmed by medical history, physical examination and clinical laboratory tests of blood and urine at the time of screening
- Normal semen analysis defined by the WHO Laboratory Manual for the Examination and Processing of Human Semen (6th Edition), based on the average of two semen samples ≥2 days and ≤7 days apart
- In the opinion of the Investigator, subject is suitable to undergo a vasectomy as a form of long-term contraception
- Agreement to use an effective method of contraception during the entire clinical trial until the planned vasectomy
- Lives in close proximity to the trial site to enable provision of fresh semen samples unless the subject agrees to provide semen samples at the trial site or laboratory
Exclusion Criteria:
- (On exam, has any of the following); one or both vasa not present, abnormal scrotum, large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intrascrotal mass that would make the subject not suitable for the study.
- Prior testicular surgery, testicular injury or prior vasectomy with vasovasostomy (vasectomy reversal)
- Recurrent pain with ejaculations
- Has known allergic reaction to sulfur-containing products or has had a prior severe allergic response to injectable or implantable devices
- Has local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, or tender (inflamed) tip of the penis, but may be enrolled after resolution of an acute infection
- History of prostatitis or benign prostatic hypertrophy requiring treatment
- Has undergone prior chemotherapy
- Has known current coagulopathy or other bleeding disorders
- Currently taking or planning to take any type of systemic medication which could affect sperm count or ejaculation (e.g., anabolic steroids, chemotherapy, alpha blocker)
- Subjects with cystic fibrosis
- Subjects with a history of inguinal hernia repair
- Vulnerable subjects (e.g., subjects with cognitive challenges, incarcerated, etc.)
- Currently participating in another study involving an investigational device or drug (or has participated in a study within the last 30 days prior to screening).
- Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities
- In the opinion of the Investigator, there are issues or concerns that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study
- Has any condition that, in the opinion of the Investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Peräkkäinen tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Group 1: Occlusion Procedure
This will be Group 1. Group1 will have the occlusion procedure but will not have the reversal procedure. |
The occlusion system comprised of the Delivery Lumen Access Device and Vasalgel. |
|
Kokeellinen: Group 2: Reversal Procedure
This will be Group 2. Group 2 will have both the occlusion and reversal procedure. |
The occlusion system comprised of the Delivery Lumen Access Device and Vasalgel. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Study subjects achieving azoospermia
Aikaikkuna: Starting at the 30 day follow-up visit
|
Total number of subjects (N=40) achieving azoospermia |
Starting at the 30 day follow-up visit
|
|
Study subjects that return to baseline semen levels
Aikaikkuna: Correlating to Outcome 1, that follow-up timepoint at which azoospermia is reached starting at the 30 day follow-up
|
Total number of subjects (N=10) that return to baseline semen levels after reversal |
Correlating to Outcome 1, that follow-up timepoint at which azoospermia is reached starting at the 30 day follow-up
|
|
Adverse Events
Aikaikkuna: From the first subjects screening visit through the last subjects 14 Day phone follow up visit.
|
Rate and severity of adverse events. |
From the first subjects screening visit through the last subjects 14 Day phone follow up visit.
|
|
Subject Comfort
Aikaikkuna: From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
|
Subject Comfort Assessment Scale Post Occlusion and Reversal |
From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
|
|
Histology
Aikaikkuna: From the first subjects occlusion visit until the last subjects vasectomy, approximately 9 months
|
Excised portion of the vas deferens will be prepared with formalin for histological evaluation |
From the first subjects occlusion visit until the last subjects vasectomy, approximately 9 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Subject Satisfaction/Comfort Assessment
Aikaikkuna: From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
|
Patient satisfaction questions along with NRS pain scale are being utilized to determine the comfort of the patient |
From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Homi Zargar, MD, Western Urology
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
- CIP102
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Yhdysvalloissa valmistettu ja sieltä viety tuote
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .