发布时间 : 星期一 文章Colonair Clinical Trial Report更新完毕开始阅读
Colonair LLC IDE G070116 Final Report
Date May 29th, 2009 Page - 2 –
THE BASICS
A. Device Name and Indication for Use
The Colonair 1000 is intended to be used for pumping air into the colon, or large intestine, through the anus and to reduce the symptoms and side effects of Irritable Bowel Syndrome with constipation (IBS-C) and Chronic Constipation.
B.
Name: Antoine Garabet Title: Operations Manager
E-mail: Tony.garabet@yahoo.com
C.
Sponsor’s Name, Address, Phone and Fax Number
Company: Colonair, LLC
Address: 678 South Rancho Simi Drive Covina, CA 91724
Tel: 626-391-1298 Fax:626-963-5441
Contact Person
CONFIDENTIAL Colonair LLC IDE G070116 Final Report
Date May 29th, 2009 Page - 3 –
I.
STUDY SUMMARY A.
Brief Summary of Study Progress in Relation to Investigational Plan The original study entitled: “A Feasibility Study of the Safety and
Efficacy of the Colonair-1000 Colon Insufflation Device in the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)”was submitted to FDA on 7/4/2007. The proposal was for a
feasibility study to evaluate the safety of the Colonair 1000.
The Feasibility study was approved on March 7th, 2008 (conditionally) for oneinstitution and 5-7 subjects. The first subject was treated in May 2008 and the last subject was treated in February 2009. Subjects were followed 12 weeks post-enrollment. A total of 12subjects were enrolled at one sites. There were zero adverse events in the Feasibility study.
Colonairsubmitted its first Progress Report for the Feasibility Study on
7/21/2008. At that time, Colonair requested to revise the protocol by allowing subjects to have the experimental procedure without having a colon prep. The request to revise the protocol was conditionally approved for 7 additional
subjects on August 22nd 2008. In total, 7 subjects were enrolled and completed at the one site.
It is the intent of the sponsor to conclude the study at this juncture. The sponsor believes that the objectives of the study have been met. The safety and efficacy success criteria as set out at the beginning of the study were met (See Section F below, Summary of Results)
There were one approved sites for this study, and oneinvestigator were trained. Table 1 lists the investigational sites and the investigators participating at each site.
Table 1-Number of Investigators/Investigational Sites Investigational Site Valley Gastroenterology Consultants - Investigator(s) Dr. Samuel Mourani - B.
Number of Investigators/Investigational Sites
C.
A total of 13 subjects were enrolled, 6 in the prepped group and 7 in the
unprepped group.They were enrolled at oneclinical site. Of these, 12 subjects were treated in the feasibility study. There were 6 enrolled in the prepped group of which one was disqualified prior to the experimental procedure because she
CONFIDENTIAL Number of Subjects Enrolled
Colonair LLC IDE G070116 Final Report
Date May 29th, 2009 Page - 4 –
became pregnant during the observation period. Another subject had the
experimental procedure but was lost to follow up without adverse events. Of the 7 that enrolled in the unprepped group one was lost to follow up after the experimental procedure without adverse events. There was no compassionate use case. The number of subjects enrolled at each site, including protocol deviations is provided in Table 2.
Table 2 Number of Subjects Enrolled at Each Site Prepped 6 5 4 Unprepped 7 6 6 Total 13 12 10 Compassionate Use 0 Investigational Site Status Dr. Samuel Mourani Enrolled Had EP Competed
D.
The number of devices shipped to each site is provided in Table 3.
Table 3 Number of Devices and Disposable Units Shipped to Each Site
Investigational Site Description Dr. Samuel Mourani Main device Colonair 1000 1 1 Disposable Tubing 12 12 Number of Devices Shipped
E.
TOTAL Disposition of All Devices Shipped
A total of one devices were shipped to investigational sites, of which one were used during the study. The one Colonair-1000 device that was delivered to Dr. Mourani’s office was returned to the company, and the 12 tubing systems delivered were all used and disposed of.
Table 4 provides an overview of the disposition for each device.
Table 4 Summary of Device Disposition Investigational Site Dr. Samuel Mourani Device Disposition Summary The one Colonair-1000 device that was delivered to Dr. Mourani’s office was returned to the company, and the 12 tubing systems delivered were all used and disposed of.
CONFIDENTIAL Colonair LLC IDE G070116 Final Report
Date May 29th, 2009 Page - 5 –
F.
Summary of Results of the Feasibility Study of the Safety and Efficacy of the Colonair-1000 Colon Insufflation Device in the Treatment of Constipation-Predominant, Protocol 2007-01, Version 6.1.1, Initially submitted 02/2008
CONFIDENTIAL