Recruiting

Cerene

Sponsor:

Channel Medsystems

Code:

NCT05922657

Conditions

Heavy Menstrual Bleeding

Abnormal Uterine Bleeding

Menorrhagia

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Not accepted

Interventions

Cerene

Study Details

Brief 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.

Conditions

Heavy Menstrual Bleeding

Abnormal Uterine Bleeding

Menorrhagia

Study ID

NCT05922657

Start date

Jun 9, 2023

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Scheduled for a Cerene treatment
  • 25 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 Criteria:

  • Physician discretion
  • Vulnerable populations

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Treated patients

This is a registry study with no active intervention outside standard of care. Women will be treated with Cerene per standard of care.

Interventions

Cerene

Real world use of Cerene.

Primary outcome measure

  • Re-intervention rate [ Time Frame: 12 Months ]
  • Site of service rate [ Time Frame: 12 Months ]
  • Patient quality of life [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Gerard Reilly, MD

513-231-3447gpreilly.shcrg@gmail.com

Brigette L. Tillman, RN

513-231-3447btillman.shcrg@gmail.com

Locations

Seven Hills Women's Health Centers

Recruiting

Cincinnati, Ohio, United States, 45255

Contacts

Brigette L. Tillman, RN

513-231-3447brigette_tillman@trihealth.com

Principal Investigator:

Gerard Reilly, MD

More Information

Sponsor

Channel Medsystems

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • Cerene
  • Registry
  • Cryoablation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Channel Medsystems on 2026-06-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.