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Assessment of the Safety, Side Effects and Efficacy of Interventional Cryotherapy for the Eradication of Benign Airway Disease("ICE THE BAD")


Phase 4
18 Years
N/A
Not Enrolling
Both
Benign Airway Disease, Sarcoidosis, Wegener's Granulomatosis, Rhinoscleroma, Recurrent Respiratory Papillomatosis(RRP)

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Trial Information

Assessment of the Safety, Side Effects and Efficacy of Interventional Cryotherapy for the Eradication of Benign Airway Disease("ICE THE BAD")


The proposed study is a single center pilot study consisting of up to 10 subjects with
benign airway disease. Treatment dosimetry will be up to 4, 5-second spray cycles.
Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat
bronchoscopy in the first three to seven days after the initial treatment, to check for
mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to
one bronchoscopy per week with CSA therapy for a total of four (4) treatments in the first
month. If they present with symptoms thereafter, then a repeat bronchoscopy will be
performed; if luminal obstruction is noted, then the subject will begin the treatment
protocol again. If disease exists bilaterally, only one side will be sprayed initially.


Inclusion Criteria:



- 18 years of age

- Deemed a candidate for cryotherapy based on physician physical or medical history
review

- Deemed operable based on institutional criteria.

Exclusion Criteria:

- Pregnant or nursing

- Planning to sire a child while enrolled in the study

- Known history of unresolved drug or alcohol dependency that would limit ability to
comprehend or follow instructions related to informed consent, post-treatment
instructions, or follow-up guidelines.

- Refusal or inability to give consent.

- Concurrent chemotherapy.

- Prior radiation therapy which involved the any area between the vocal chords and the
diaphragm

- Medical contraindication or potential problem that would preclude study participation

- Concurrent participation in other experimental studies Uncontrolled coagulopathy or
bleeding diathesis

Serious medical illness, including:

- Uncontrolled congestive heart failure

- Uncontrolled angina

- Myocardial infarction

- Cerebrovascular accident within 6 months prior to study entry

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The effectiveness endpoint is an improvement in luminal patency following cryospray treatment along with visual confirmation of an absence of scarring and stricturing of the airway. Primary safety endpoint is the reporting of all adverse events.

Outcome Time Frame:

24 months

Safety Issue:

Yes

Principal Investigator

Michael Machuzak, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Institutional Review Board

Study ID:

15-00026

NCT ID:

NCT00747461

Start Date:

October 2008

Completion Date:

March 2011

Related Keywords:

  • Benign Airway Disease
  • Sarcoidosis
  • Wegener's Granulomatosis
  • Rhinoscleroma
  • Recurrent Respiratory Papillomatosis(RRP)
  • Benign Airway Disease
  • Airway Injury
  • Sarcoidosis
  • Wegener's Granulomatosis
  • Rhinoscleroma
  • Recurrent Respiratory Papillomatosis(RRP)
  • Rhinoscleroma
  • Sarcoidosis
  • Wegener Granulomatosis
  • Papilloma
  • Respiratory Tract Infections
  • Papillomavirus Infections

Name

Location
Cleveland Clinic Foundation Cleveland, Ohio  44195