Lung Diseases, Obstructive, Recurrent Respiratory Papillomatosis, Rhinoscleroma, Sarcoidosis, Wegener's Granulomatosis
Conditions
Keywords
Benign Airway Disease, Airway Injury, Sarcoidosis, Wegener's Granulomatosis, Rhinoscleroma, Recurrent Respiratory Papillomatosis(RRP)
Brief summary
The purpose of this study is to evaluate the safety, effectiveness, and side effects of the CryoSpray AblationTM System (CryoSpray AblationTM, CSA or cryospray therapy) to treat benign airway disease in the lung using liquid nitrogen sprayed through a catheter via flexible fiber optic bronchoscopy (FFB)
Detailed description
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.
Interventions
DEVICECryoSpray Ablation
Cryospray Ablation up to 4 -5 second cycles for up to 4 treatments in the first 30 days
Sponsors
CSA Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Luminal Patency Following Cryospray Treatment | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Durability | 12 months | need for additional treatments within specified period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cryo Spray Ablation subjects will receive up to 4 -5 second cycles of cryospray ablation | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | study terminated by sponsor | 5 |
Baseline characteristics
| Characteristic | Cryo Spray Ablation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Improvement in Luminal Patency Following Cryospray Treatment
Time frame: 30 days
Population: study terminated by Sponsor-data not analyzed
Secondary
Treatment Durability
need for additional treatments within specified period
Time frame: 12 months
Population: study terminated-no subjects analyzed.