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NCT05922657 · ClinicalTrials.gov registry record
A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device
A clinical trial of Menorrhagia and Heavy Menstrual Bleeding, sponsored by Channel Medsystems.
- Recruiting
- Registry status
- 300
- Enrollment target
- 2
- Study locations
NCT05922657: Recruiting study of Menorrhagia and Heavy Menstrual Bleeding, sponsored by Channel Medsystems.
NCT05922657 is a study of Menorrhagia and Heavy Menstrual Bleeding that is actively recruiting participants, run by Channel Medsystems. The registered enrollment target is 300 participants, above the 199-participant average among 10 other Menorrhagia trials with a reported enrollment target (51% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05922657, a study of Menorrhagia and Heavy Menstrual Bleeding, is actively recruiting participants, sponsored by Channel Medsystems.
- RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
The cumulative re-intervention rate at 12 months will be compared to the pivotal clinical study.
Conditions Studied
Interventions
- DEVICE Cerene
Study Locations (2)
New Jersey
- Axia Women's Health / Rubino OB/GYN Group - West Orange
Ohio
- Seven Hills Women's Health Centers - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-06-09 |
| Est. Completion | 2027-12-31 |
What NCT05922657 shows while recruiting
NCT05922657 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 199-participant average among 10 other Menorrhagia trials with a reported enrollment target (51% higher).
The record links to 3 conditions, with Menorrhagia appearing as the primary indexed condition, and to 1 intervention - of which Cerene is the first listed.
NCT05922657 reports a single indexed study location in New Jersey, Ohio.
Frequently Asked Questions
What is clinical trial NCT05922657 about?
NCT05922657 is a clinical study titled "A Registry to Gather Real World Use Data on the Cerene® Cryotherapy 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 bri...
What is the current status of trial NCT05922657?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2023-06-09. Estimated completion is 2027-12-31.
What conditions does trial NCT05922657 study?
This clinical trial studies the following conditions: Menorrhagia, Heavy Menstrual Bleeding, Abnormal Uterine Bleeding.
What interventions are being tested in trial NCT05922657?
The interventions under investigation include: Cerene (DEVICE).
Who is sponsoring clinical trial NCT05922657?
This trial is sponsored by Channel Medsystems, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05922657 being conducted?
This trial has 2 study locations across New Jersey, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Menorrhagia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05922657's enrollment target sits among peer trials
300 2nd of 10 the highest of 10 other Menorrhagia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Menorrhagia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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