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

Part of paid clinical trials in West Orange, New Jersey.

Sponsor
Channel Medsystems
Study ID
NCT05922657
Status
Recruiting
Apply to this trial

Conditions

  • Abnormal Uterine Bleeding
  • Heavy Menstrual Bleeding
  • Menorrhagia

Eligibility Criteria

Sex
FEMALE
Age
25 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cerene — DEVICE
    Real world use of Cerene.

Study Details

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.

Key Dates

Start date
Jun 9, 2023
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Re-intervention rate [ Time Frame: 12 Months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Axia Women's Health / Rubino OB/GYN GroupWest OrangeNew Jersey07052
Joanne Serra, RN
[email protected]
862-444-2524
Robert Rubino, MD (PRINCIPAL_INVESTIGATOR)
Seven Hills Women's Health CentersCincinnatiOhio45255
Brigette L. Tillman, RN
[email protected]
513-231-3447
Gerard Reilly, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in West Orange, NJ

By research site
Axia Women's Health / Rubino OB/GYN Group· West Orange, NJSeven Hills Women's Health Centers· Cincinnati, OH

Related Studies