Radiation ProctitisPhase 4CSALGI2NCT00756197
CryoSpray Ablation(TM)to Determine Safety and Feasibility in Radiation Induced Proctitis
A Phase 4 study testing Cryo Spray Ablation Group 1 and Cryo Spray Ablation Group 2 in people with Radiation Proctitis and Radiation Induced Proctitis, run by CSA Medical, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Proctitis, Radiation Induced Proctitis
- What is being tested?
- Cryo Spray Ablation Group 1 and Cryo Spray Ablation Group 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Sep 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years of age
- Have radiation induced proctitis
Who cannot join
- Pregnant or nursing
- Planning to become pregnant during the course of the study
- 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.
- 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
- Refusal or inability to give consent.
Show all 11Show fewer
- Concurrent chemotherapy.
- Medical contraindication or potential problem that would preclude study participation
- Concurrent participation in other experimental studies
- Uncontrolled coagulopathy or bleeding diathesis
- Portal hypertension due to cirrhosis manifest by esophageal, gastric or rectal varices
About this study
Official title: A Single Center Pilot Study of CryoSpray Ablation(TM) to Determine Safety and Feasibility in Radiation Induced Proctitis (CSA LGI-2)
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.
Read the detailed description
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.
- Conditions
- Radiation Proctitis, Radiation Induced Proctitis
- Being tested
- Cryo Spray Ablation Group 1, Cryo Spray Ablation Group 2
- Keywords
- Radiation Proctitis, Radiation Induced Proctitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryo Spray Ablation Group 1Device
Also called CryoSpray Ablation, Cryospray, Cryotherapy, Cryo Spray Ablation
Cryo Spray Ablation
Cryo Spray Ablation Group 2Device
cryo spray ablation
| Study group | Role | What they receive |
|---|---|---|
| Cryo Spray Ablation Group 1 | Experimental | 4 cycles of 10 seconds each Receives: Device: Cryo Spray Ablation Group 1 |
| Cryo Spray Ablation Group 2 | Experimental | 2 cycles of 20 seconds each Receives: Device: Cryo Spray Ablation Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoints for this study are patient safety, treatment efficacy, and feasibility of cryospray therapy in subjects with radiation proctitis.
Measured: End of Study
Secondary outcomes (1)
The secondary endpoints for the study are the cataloging of side effects, and tissue response as determined by endoscopic visual evaluation.
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2009 (estimated)
- Study completionSep 2009 (estimated)
Why it stopped: Considering more robust design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Radiation ProctitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSA Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Lee Krinsky, D.O., Principal investigator, VA San Diego Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756197
- Sponsor's protocol ID
- 17-00016-00
- Acronym
- CSALGI2
- Status last verified
- Aug 2015
- First submitted
- 18 Sep 2008
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnston MH, Eastone JA, Horwhat JD, Cartledge J, Mathews JS, Foggy JR. Cryoablation of Barrett's esophagus: a pilot study. Gastrointest Endosc. 2005 Dec;62(6):842-8. doi: 10.1016/j.gie.2005.05.008.
PubMed 16301023Johnston CM, Schoenfeld LP, Mysore JV, Dubois A. Endoscopic spray cryotherapy: a new technique for mucosal ablation in the esophagus. Gastrointest Endosc. 1999 Jul;50(1):86-92. doi: 10.1016/s0016-5107(99)70352-4.
PubMed 10385730Ell C, May A, Gossner L, Pech O, Gunter E, Mayer G, Henrich R, Vieth M, Muller H, Seitz G, Stolte M. Endoscopic mucosal resection of early cancer and high-grade dysplasia in Barrett's esophagus. Gastroenterology. 2000 Apr;118(4):670-7. doi: 10.1016/s0016-5085(00)70136-3.
PubMed 10734018Champion G, Richter JE, Vaezi MF, Singh S, Alexander R. Duodenogastroesophageal reflux: relationship to pH and importance in Barrett's esophagus. Gastroenterology. 1994 Sep;107(3):747-54. doi: 10.1016/0016-5085(94)90123-6.
PubMed 8076761Eisen GM, Sandler RS, Murray S, Gottfried M. The relationship between gastroesophageal reflux disease and its complications with Barrett's esophagus. Am J Gastroenterol. 1997 Jan;92(1):27-31.
PubMed 8995932Johnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. doi: 10.1016/s1052-5157(03)00044-8.
PubMed 14629105Cash BD, Johnston LR, Johnston MH. Cryospray ablation (CSA) in the palliative treatment of squamous cell carcinoma of the esophagus. World J Surg Oncol. 2007 Mar 16;5:34. doi: 10.1186/1477-7819-5-34.
PubMed 17367523Pinsonneault C, Fortier J, Donati F. Tracheal resection and reconstruction. Can J Anaesth. 1999 May;46(5 Pt 1):439-55. doi: 10.1007/BF03012943.
PubMed 10349923Dumot JA. Cryotherapy Ablation for Esophageal HGD or IMCA in High Risk, Non-Surgical Patients. DDW2007 Abstract submission. Cleveland Clinic Foundation (pending publication)
Greenwald BD. CryoSpray Ablation of Early Esophageal Cancer. DDW 2007 Abstract submission. University of Maryland Medical Center. (pending publication)
Johnston M, Horwhat J, Dubois A, Schoenfeld P. Endoscopic cryotherapy in the swine esophagus: A follow-up study (Abstract). Gastrointestinal Endoscopy 49:AB126, 1999.
Johnston MH, Horwhat JD, Haluska, Moses FM. Depth of injury following endoscopic spray cryotherapy: EUS assisted evaluation of mucosal ablation and subsequent healing in the swine model (Abstract). Gastrointestinal Endoscopy 51: AB98, 3462, 2000.
Johnston MH. Endoscopic cryotherapy: A new ice age in gastroenterology? Medscape Gastroenterology 2: 187, 2000.
Eastone JA, Horwhat D, Haluska O, Mathews J, Johnston M. Cryoablation of swine esophageal mucosa: A direct comparison to argon plasma coagulation (APC) and multipolar electrocoagulation (MPEC) [Abstract] Gastrointestinal Endoscopy 53: A3448, 2001.
Johnston MH, Eastone JA, Horwhat JD. Reversal of Barrett's esophagus with cryotherapy [Abstract]. American Journal of Gastroenterology 98(9 Suppl): A30, S11, 2003.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Pilot Study of CryoSpray Ablation(TM) to Determine Safety and Feasibility in Radiation Induced Proctitis (CSA LGI-2)
- ClinicalTrials.gov ID
- NCT00756197
- Acronym / sponsor ID
- CSALGI2 / 17-00016-00
- Conditions
- Radiation Proctitis, Radiation Induced Proctitis
- Keywords
- Radiation Proctitis, Radiation Induced Proctitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Considering more robust design.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CSA Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryo Spray Ablation Group 1 | Experimental | Device: Cryo Spray Ablation Group 14 cycles of 10 seconds each |
| Cryo Spray Ablation Group 2 | Experimental | Device: Cryo Spray Ablation Group 22 cycles of 20 seconds each |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years of age
- Have radiation induced proctitis
Key exclusion criteria (11 listed)
- Pregnant or nursing
- Planning to become pregnant during the course of the study
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryo Spray Ablation Group 1Also: CryoSpray Ablation, Cryospray, Cryotherapy, Cryo Spray AblationCryo Spray Ablation | Device | Cryo Spray Ablation Group 1 |
| Cryo Spray Ablation Group 2cryo spray ablation | Device | Cryo Spray Ablation Group 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
- Background: PubMed 16301023Johnston MH, Eastone JA, Horwhat JD, Cartledge J, Mathews JS, Foggy JR. Cryoablation of Barrett's esophagus: a pilot study. Gastrointest Endosc. 2005 Dec;62(6):842-8. doi: 10.1016/j.gie.2005.05.008.
- Background: PubMed 10385730Johnston CM, Schoenfeld LP, Mysore JV, Dubois A. Endoscopic spray cryotherapy: a new technique for mucosal ablation in the esophagus. Gastrointest Endosc. 1999 Jul;50(1):86-92. doi: 10.1016/s0016-5107(99)70352-4.
- Background: PubMed 10734018Ell C, May A, Gossner L, Pech O, Gunter E, Mayer G, Henrich R, Vieth M, Muller H, Seitz G, Stolte M. Endoscopic mucosal resection of early cancer and high-grade dysplasia in Barrett's esophagus. Gastroenterology. 2000 Apr;118(4):670-7. doi: 10.1016/s0016-5085(00)70136-3.
- Background: PubMed 8076761Champion G, Richter JE, Vaezi MF, Singh S, Alexander R. Duodenogastroesophageal reflux: relationship to pH and importance in Barrett's esophagus. Gastroenterology. 1994 Sep;107(3):747-54. doi: 10.1016/0016-5085(94)90123-6.
- Background: PubMed 8995932Eisen GM, Sandler RS, Murray S, Gottfried M. The relationship between gastroesophageal reflux disease and its complications with Barrett's esophagus. Am J Gastroenterol. 1997 Jan;92(1):27-31.
- Background: PubMed 14629105Johnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. doi: 10.1016/s1052-5157(03)00044-8.
- Background: PubMed 17367523Cash BD, Johnston LR, Johnston MH. Cryospray ablation (CSA) in the palliative treatment of squamous cell carcinoma of the esophagus. World J Surg Oncol. 2007 Mar 16;5:34. doi: 10.1186/1477-7819-5-34.
- Background: PubMed 10349923Pinsonneault C, Fortier J, Donati F. Tracheal resection and reconstruction. Can J Anaesth. 1999 May;46(5 Pt 1):439-55. doi: 10.1007/BF03012943.
- BackgroundDumot JA. Cryotherapy Ablation for Esophageal HGD or IMCA in High Risk, Non-Surgical Patients. DDW2007 Abstract submission. Cleveland Clinic Foundation (pending publication)
- BackgroundGreenwald BD. CryoSpray Ablation of Early Esophageal Cancer. DDW 2007 Abstract submission. University of Maryland Medical Center. (pending publication)
- BackgroundJohnston M, Horwhat J, Dubois A, Schoenfeld P. Endoscopic cryotherapy in the swine esophagus: A follow-up study (Abstract). Gastrointestinal Endoscopy 49:AB126, 1999.
- BackgroundJohnston MH, Horwhat JD, Haluska, Moses FM. Depth of injury following endoscopic spray cryotherapy: EUS assisted evaluation of mucosal ablation and subsequent healing in the swine model (Abstract). Gastrointestinal Endoscopy 51: AB98, 3462, 2000.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Lee Krinsky, D.O. principal investigator
VA San Diego Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cryo Spray Ablation Group 1 and Cryo Spray Ablation Group 2 in people with Radiation Proctitis and Radiation Induced Proctitis, run by CSA Medical, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00756197, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.