This is a feasibility study of the System to assess safety and performance in patients scheduled to undergo esophagectomy.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Histological aspect of tissue after balloon based cryoabalation:
(1) the percentage of mucosa ablated (**Ablation** is defined as any sign of
irreversible injury (necrosis)).
(2) the anatomic depth of injury.
(3) a detailed description of the type of injury at each depth of the
esophageal wall.
Secondary outcome
(1) Deployment ease/endoscope compatibility.
(2) Flow of the cryogenic fluid.
(3) Balloon pressure.
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. The experience to date
supports the need for further investigation in a human clinical trial.
Study objective
This is a feasibility study of the System to assess safety and performance in
patients scheduled to undergo esophagectomy.
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 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. BE cells are ablated as the balloon comes into contact with the
esophagus for less than 15 seconds. After ablation, the System is repositioned
for additional ablation or withdrawn.
Study burden and risks
If patients participate, their regular endoscopy will be prolonged with 15
minutes and 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 1 day after the
cryoablation (unless the esophagectomy will follow directly upon the endoscopic
treatment). Finally, the patient may experience some temporary mild pain which
can be treated with acetaminophen if necessary.
303 Convention Way, Suite 1
Redwood City, CA 94063
US
303 Convention Way, Suite 1
Redwood City, CA 94063
US
Listed location countries
Age
Inclusion criteria
a) Patient must have a minimum of 2.0 cm of non-ulcerated, non-inflammatory columnar-lined esophagus or squamous esophageal lined tissue suitable for ablation. A patient may be treated with up to 2 zones of ablation
b) Patient is 18 to 80 years of age at the time of consent (inclusive).
c) Patient has provided written Informed Consent Form (IFC) using a form that has been approved by the Institution*s reviewing IRB/EC.
d) Patient is willing and able to comply with study requirements.
e) Patient*s esophagectomy is clinically necessary due to reasons unrelated to this study.
f) Patient is deemed operable per standard institutional criteria.
Exclusion criteria
a) Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to IFC, post treatment instructions or follow-up guidelines.
b) Patient refuses or is unable to provide written informed consent.
c) Patient has or is currently undergoing endoscopic ablation therapy within 4 cm from the proposed treatment area including, but not limited to cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
d) Patient has esophageal narrowing limiting access to the intended site of ablation.
e) Patient is undergoing or has recently undergone chemotherapy (within 15 days or WBC below normal by institutional criteria or standards).
f) Patient is undergoing or has recently undergone radiation therapy which involved the esophagus (within 15 days or WBC below normal by institutional criteria or standards).
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 | NL33853.018.10 |