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NCT05830149 · ClinicalTrials.gov registry record · NA
Safety and Treatment of Cryoinsufflation in Treatment of Hidradenitis Suppurativa
A NA study, sponsored by Henry Ford Health System.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT05830149 is a NA study that was terminated before completion, run by Henry Ford Health System. The registered enrollment target is 1 participants.
The verdict
NCT05830149, a NA study, was terminated before completion, sponsored by Henry Ford Health System.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
Hidradenitis suppurativa (HS) is a chronic, socially and cosmetically debilitating disease. It typically manifests as nodules and abscesses that ultimately can progress to form deep sinus tracts, fistulas, and scarring. The lesions are often very painful and can chronically drain malodorous fluid, which can leave affected individuals uncomfortable and self-conscious, or even debilitated. Treatment presents significant challenges and frustration to both the patient and the provider. Measures such as topical antibiotic and antiseptic washes are generally thought to be beneficial for the treatment of early stage HS. When this is not efficacious, systemic antibiotics are prescribed. In some patients, disease remains refractory to these treatments and their fistulas and tracts progress to scarring. In some patients, the disease continues to progress. In these patients who fail conservative medical management and minimally invasive procedures, such as deroofing, is the next step in the therapeutic ladder. In deroofing, the skin overlying the sinus tract is cut, exposing the floor of the tract. These wounds are left open to heal by secondary intention. Also with this technique, recurrence is common. In this study, investigators propose the use of cryoinsufflation for management of the sinus tracts in hidradenitis suppurativa. In this technique, local anesthesia will be administered to the tract area with lidocaine hydrochloride 1% or a similar numbing medication. A needle will be mounted on a cryosurgical unit. The needle will be instered into the tracts at one location on one side of the body and liquid nitrogen will be administered. This will result in obliteration of the sinus tract. This intervention may prevent disease progression and ameliorate the need for these patients to surgically intervene on their disease. Overall, this would result in improved cosmesis, decreased pain, and improved patient satisfaction. The objective of this prospective, randomized controlle
Interventions
- OTHER Cryoinsufflation
- OTHER Deroofing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-02-20 |
| Est. Completion | 2018-04-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05830149
The ClinicalTrials.gov registry entry for NCT05830149 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Henry Ford Health System, which has 234 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cryoinsufflation is the first listed.
NCT05830149 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05830149 about?
NCT05830149 is a clinical study titled "Safety and Treatment of Cryoinsufflation in Treatment of Hidradenitis Suppurativa". Hidradenitis suppurativa (HS) is a chronic, socially and cosmetically debilitating disease. It typically manifests as nodules and abscesses that ultimately can progress to form deep sinus tracts, fistulas, and scarring. The lesions are often very painful and can chronically drain malodorous fluid, w...
What is the current status of trial NCT05830149?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2018-02-20. Estimated completion is 2018-04-18.
What interventions are being tested in trial NCT05830149?
The interventions under investigation include: Cryoinsufflation (OTHER), Deroofing (OTHER).
Who is sponsoring clinical trial NCT05830149?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
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