A Phase 4 interventional study of Cryo Spray Ablation Group 1 and Cryo Spray Ablation Group 2 in Radiation Proctitis and Radiation Induced Proctitis, sponsored by CSA Medical, Inc.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-07.
Sponsored by CSA Medical, Inc. · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate the safety, feasibility, tissue response, and subject side effects of liquid nitrogen sprayed through a catheter (CryoSpray AblationTM, "CSA" or "cryospray therapy") via endoscope in subjects with radiation induced proctitis.
The proposed study is a single center, ten patient pilot study to evaluate the safety and feasibility of sprayed liquid nitrogen through a catheter via endoscope in subjects with radiation proctitis. There will be two groups. Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy. Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.
27 studies on the registry are indexed under Proctitis; 6 are open to participants now.
Browse Proctitis studies →CSA Medical, Inc. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Subject has prior or concurrent ablation therapy including, but not limited to, photodynamic therapy, multipolar electro coagulation, argon plasma coagulation, laser treatment, radio frequency, etc
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
4 cycles of 10 seconds each
Device: Cryo Spray Ablation Group 1
2 cycles of 20 seconds each
Device: Cryo Spray Ablation Group 2
Cryo Spray Ablation
Also known as: CryoSpray Ablation, Cryospray, Cryotherapy, Cryo Spray Ablation
cryo spray ablation
The primary endpoints for this study are patient safety, treatment efficacy, and feasibility of cryospray therapy in subjects with radiation proctitis.
Time frame: End of Study
The secondary endpoints for the study are the cataloging of side effects, and tissue response as determined by endoscopic visual evaluation.
Time frame: End of Study
No study locations are listed for this record.
This study is withdrawn, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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CSA Medical, Inc.