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

July 7, 2023 updated by: Channel Medsystems

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cerene was approved by the FDA in March 2019 for endometrial cryoablation in premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete. The primary objective of the Progress registry is to bridge the gap between clinical results and outcomes reported during the pivotal study of Cerene (the CLARITY Study) and those observed during its real-world use. The Progress registry will gather prospective, observational data on up to 300 women that underwent a Cerene treatment. Patients and physicians will complete surveys. Surveys will include patient demographic characteristics and quality of life measures at baseline, procedural details, and post-operative clinical outcomes and quality of life measures.

Patient participation is expected to last approximately 13 months, from the time of patient enrollment to 12 months post treatment. The study will end after the last participating patient in completes her 12 month visit.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Cerene
Real world use of Cerene.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-intervention rate
Time Frame: 12 Months
The cumulative re-intervention rate at 12 months will be compared to the pivotal clinical study.
12 Months
Site of service rate
Time Frame: 12 Months
The mix of Cerene treatments performed at different sites of service will be tabulated.
12 Months
Patient quality of life
Time Frame: 12 Months
The patient's quality of life at baseline and 12 Months will be compared.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician survey
Time Frame: 12 Months
Each physician user will be surveyed on several topics related to the device.
12 Months
Cost analysis
Time Frame: 12 Months
A cost analysis of Cerene treatments for different sites of service may be performed.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Channel Medsystems

Investigators

  • Study Chair: Edward Yu, MBA, Senior Executive VP of Clinical, Medical, and Regulatory Affairs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2023

Primary Completion (Estimated)

June 9, 2025

Study Completion (Estimated)

July 9, 2025

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

June 19, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTL-2023-N01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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