CryoSpray Ablation(TM)to Determine Safety and Feasibility in Radiation Induced Proctitis (CSALGI2)

CSA Medical

Status and phase: Withdrawn; Phase 4

Conditions: Radiation Induced Proctitis; Radiation Proctitis

Treatments: Device: Cryo Spray Ablation Group 2; Device: Cryo Spray Ablation Group 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT00756197

17-00016-00

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years of age
• Have radiation induced proctitis

Exclusion criteria

• 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.
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Cryo Spray Ablation Group 1

Experimental group

Description:

4 cycles of 10 seconds each

Treatment:

Device: Cryo Spray Ablation Group 1

Cryo Spray Ablation Group 2

Experimental group

Description:

2 cycles of 20 seconds each

Treatment:

Device: Cryo Spray Ablation Group 2