This is a feasibility study of the Balloon-based Focal Cryoablation System to assess safety and performance in patients with a Barretts esophagus
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
1) Performance of the balloon-based focal cryoablation system
2) Adverse events by using the balloon-based focal cryoablation system
3) Esophageal stricture formation and assessment of clinical dysphagia after
using the balloon-based focal cryoablation system
Secondary outcome
1) Patients pain scores
Background summary
Barrett's Esophagus (BE) is a premalignant lesion which can lead to esophageal
adenocarcinoma. This particular cancer is one of the most rapidly increasing
and deadliest cancers in the western world. Patients with BE are up to 40 times
more at risk of adenocarcinoma than individuals without BE. Once diagnosed with
BE, a patient enters a life-long surveillance program in which upper endoscopy
with biopsy are performed to survey the progression of the Barrett's tissue to
cancer. For more than 20 years, many technologies have been evaluated for
ablation of BE. Elimination of BE and restoration of squamous esophageal lining
has been demonstrated through ablation; however, no ablation technology
currently provides the necessary attributes for wide-spread adoption. The
CryoBalloon Ablation System (System) is designed to address many of the
limitations of ablation technologies. The simplicity of the System allows for
many potential benefits to the patient, the physician, and hospital. Some of
the benefits may include a shorter and safer procedure, an easier deployment
minimizing the need for anesthesiology, and smaller inventory requirements and
no capital equipment improving capital resource utilization The System has
undergone acute and chronic animal testing. The testing was conducted to study
the safety, deliverability and performance characteristics of the System. The
studies were conducted for the evaluation of the device in a normal pig
esophagus at dimensions very similar to a human esophagus. General follow-up
time frames were either 4 days or 28 days. Hereafter, a human trial has been
performed with the circumferential balloon-cryoablation system. This too
appeared safe and feasible in the treatment of a human esophagus. Next step in
the development of ballon-based cryoablation is to test the Focal cryoablation,
which will give the opportunity to ablate small pieces of Barretts epithelium
without the use of ablating circumferentially in the esophagus.
Study objective
This is a feasibility study of the Balloon-based Focal Cryoablation System to
assess safety and performance in patients with a Barretts esophagus
Study design
Prospective, multi-center, single-arm and non-randomized.
Intervention
Endoscopic balloon based cryoablation. The System has two main components: the
delivery catheter with balloon (2 types: circumferential and focal) probe and a
disposable handle containing the cryogenic fluid. Deployed through the working
channel of an endoscope, the operation of the System is very similar to the
deployment of dilatation balloons. Once deployed, the balloon is simultaneously
inflated and cooled with cryogenic fluid delivered from the handle. In the
focal ablation balloon the cryogenic fluid will only cool a focal area from one
hole in the shaft. BE cells are ablated as the balloon comes into contact with
the esophagus for 6, 8 or 10 seconds. After ablation, the System is
repositioned for additional ablation or withdrawn.
Study burden and risks
Patients will undergo 2 gastroscopies in this study, which will both be
performed for medical reasons anyway. The treatment with the focal cryoablation
system will be performed when a patient in scoped for imaging purposes of his
Barretts esophagus. This will prolong the endoscopy by 15 minutes.
During follow-up endoscopy a biopsy will be taken from the ablated zone and a
thorough inspection of the esophagus will be performed, after which the regular
treatment will be performed as scheduled for regular medical reasons. This
extra biopsy and inspection will prolong the enoscopy by 5 -10 minutes.
Patients need to adhere to a soft diet during 2 days after the cryoablation
(unless the esophagectomy will follow directly upon the endoscopic treatment).
Furthermore patients will be contacted by telephone 2 days after the
cryoablation.
303 Covention Way Suite 1
CA 94063 Redwood City
US
303 Covention Way Suite 1
CA 94063 Redwood City
US
Listed location countries
Age
Inclusion criteria
a) Patients with known high grade dysplasia or early adenocarcinoma in BE.
b) Patients scheduled for ablation- and/or EMR-therapy gastroscopies, during which cryoablation may be performed.
c) Patient is 18 to 80 years of age at the time of consent (inclusive).
d) Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution*s reviewing IRB/EC.
e) Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
f) Patient is deemed operable per standard institutional criteria.
g) Each patient has a C&M classification of C*2 and/or M*3.
h) Each patient will have one area of BE or one island of BE >1 cm2 where the Cryoballoon Focal Ablation System can be successfully positioned within the BE lesion. Cryoballoon ablation should be performed within 1 cm of the proximal border of the Barrett*s epithelium.
i) BE lesion within the treatment zone should be flat.
Exclusion criteria
a) Patient with endoscopically active inflammation in the treatment zone
b) Esophageal stenosis preventing advancement of a therapeutic endoscope and/or within 4 cm of treatment zone.
c) Patient has a 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.
d) Patient refuses or is unable to provide written informed consent.
e) Patients that received prior treatment with any energy-based ablation system.
f) Endoscopically visible abnormalities such as masses or nodules within 4 cm of the treatment zone.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL41547.018.12 |