Clinical trial · Observational

trūFreeze® Spray Cryotherapy Patient Registry

NCT01802203CI-TRIAL-00059852completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

To collect efficacy and outcomes data related to the use of trūFreeze® spray cryotherapy for the treatment of unwanted tissue in the pulmonary and gastrointestinal settings.

Conditions

Conditions (6)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Barrett Esophagus	—	UNRESOLVED	—
Bronchial Neoplasm	—	UNRESOLVED	—
Esophageal Dysplasia	Esophageal Intraepithelial Neoplasia	ALIAS	0.90
Esophageal Neoplasm	Esophageal Neoplasm	ONTOLOGY_EXACT	0.98
Esophageal Stenosis	—	UNRESOLVED	—
Stenosis of Bronchus or Trachea	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
truFreeze Spray Cryotherapy	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
truFreeze spray cryotherapy
description
truFreeze Spray Cryotherapy administered as routine clinical care
interventionNames
1. Device: truFreeze Spray Cryotherapy

Primary outcomes (1)

measure
Collect efficacy and outcome data related to the use of trūFreeze® spray cryotherapy for treatment of unwanted tissue in the pulmonary and gastrointestinal settings.
timeFrame
5 years
description
The registry population consists of patients who are being treated using the trūFreeze® spray cryotherapy device for the removal of unwanted tissue, such as malignant or pre-malignant conditions in the pulmonary or gastrointestinal settings.

Secondary outcomes (1)

measure
Collect safety data related to the use of trūFreeze® spray cryotherapy for treatment in the pulmonary and gastrointestinal settings.
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. GI conditions include:

   * Barrett's Esophagus (BE) with or without dysplasia
   * Squamous dysplasia
   * Esophageal cancer, any stage
2. Pulmonary conditions include:

   * Any endobronchial cancerous or precancerous disease located within the central airways
   * Any non-malignant endobronchial process of the central airways that results in abnormal mucosa (i.e. granulation tissue, papillomatosis, sarcoidosis, tuberculosis, etc.)
   * Tracheal or bronchial stenosis (malignant or benign)
   * Any pleural disease, malignant or benign All subjects are required to be able to provide written informed consent

Exclusion Criteria:

1. Gastrointestinal Exclusion Criteria

   * Contraindication to spray cryotherapy.
   * Prior treatment with spray cryotherapy. Previous or concurrent treatment using other mucosal therapies such as endoscopic mucosal resection or radiofrequency ablation is acceptable.
   * Below 18 years of age
2. Pulmonary Exclusion Criteria

   * Contraindication to spray cryotherapy.
   * Prior treatment with spray cryotherapy. Previous or concurrent treatment using other mucosal therapies is acceptable.
   * Tracheoesophageal fistula.
   * Bronchopleural fistula.
   * Current untreated pneumothorax.
   * Clinically significant hypoxia refractory to supplemental oxygen therapy.
   * Below 18 years of age

References

Publications (34)

BACKGROUNDSiegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4. PMID 22237781
BACKGROUNDHeier SK. Evaluation of candidate therapies for ablation of Barrett's in a canine model. Gastrointestinal endoscopy. 1996;43(4):337
BACKGROUNDPasricha PJ, Hill S, Wadwa KS, Gislason GT, Okolo PI 3rd, Magee CA, Canto MI, Kuo WH, Baust JG, Kalloo AN. Endoscopic cryotherapy: experimental results and first clinical use. Gastrointest Endosc. 1999 May;49(5):627-31. doi: 10.1016/s0016-5107(99)70393-7. PMID 10228263
BACKGROUNDGreenwald BD, Dumot JA, Horwhat JD, Lightdale CJ, Abrams JA. Safety, tolerability, and efficacy of endoscopic low-pressure liquid nitrogen spray cryotherapy in the esophagus. Dis Esophagus. 2010 Jan;23(1):13-9. doi: 10.1111/j.1442-2050.2009.00991.x. Epub 2009 Jun 9. PMID 19515183
BACKGROUNDGrana L, Ablin RJ, Goldman S, Milhouse E Jr. Freezing of the esophagus: histological changes and immunological response. Int Surg. 1981 Oct-Dec;66(4):295-301. PMID 7345039
BACKGROUNDLoprinzi CL, Foote RL, Michalak J. Alleviation of cytotoxic therapy-induced normal tissue damage. Semin Oncol. 1995 Apr;22(2 Suppl 3):95-7. PMID 7740323
BACKGROUNDRodgers BM, Pappelis P. Profound endoesophageal cryotherapy. Cryobiology. 1985 Feb;22(1):86-92. doi: 10.1016/0011-2240(85)90011-2. PMID 3979079
BACKGROUNDLaugier P, Berger G. Assessment of echography as a monitoring technique for cryosurgery. Ultrason Imaging. 1993 Jan;15(1):14-24. doi: 10.1177/016173469301500102. PMID 8328116
Reiser M, Drukier AK, Ultsch B, Feuerbach S. The use of CT in monitoring cryosurgery. Eur J Radiol. 1983 May;3(2):123-8.

Registry

Dates and enrollment

Start: Apr 1, 2013
Primary completion: Jan 1, 2022
Completion: Apr 1, 2022
First posted: Mar 1, 2013
Last update posted: Jul 25, 2022
Enrollment: 275 (actual)
Lead sponsor: US Endoscopy Group Inc. INDUSTRY
Keywords: Barrett esophagus, Esophageal dysplasia, Upper gastrointestinal squamous dysplasia, Esophageal cancer, Endobronchial cancer, Central airway cancer, Central airway precancerous disease, Central airway granulation tissue, Central airway papillomatosis, Central airway sarcoidosis, Central airway tuberculosis, Tracheal stenosis, Bronchial stenosis

Data updated 22 days agoSource updated Jul 25, 2022source: clinicaltrials

Locations

Locations by country (16)

Country	Sites	Recruiting
United States	16	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.