RecruitingNCT05922657

A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device

A Prospective, Observational, Multi-center Study to Gather Real World Use Data on the Effectiveness, Safety, and Site-of-service of the Cerene Device


Sponsor

Channel Medsystems

Enrollment

300 participants

Start Date

Jun 9, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Channel Medsystems, Inc., the manufacturer of the Cerene® Cryotherapy Device (Cerene), is initiating a prospective, observational registry, the Progress registry, to gather data during real world utilization of the Cerene® Cryotherapy Device (Cerene). The primary objective of this registry is to bridge the gap between clinical results and outcomes achieved and reported during the pivotal study of Cerene and those obtained during its real-world use.


Eligibility

Sex: FEMALEMin Age: 25 Years

Inclusion Criteria5

  • Scheduled for a Cerene treatment
  • years of age and older
  • Provided informed consent to participate in the registry
  • English speaking
  • Agrees to complete a survey at specified time points from baseline to 12 Months

Exclusion Criteria2

  • Physician discretion
  • Vulnerable populations

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICECerene

Real world use of Cerene.


Locations(2)

Axia Women's Health / Rubino OB/GYN Group

West Orange, New Jersey, United States

Seven Hills Women's Health Centers

Cincinnati, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05922657


Related Trials