Evaluation of NiTi Shape Memory End-to-End Compression An... | NCT00468416

Studies
Evaluation of NiTi Shape Memory End-to-End Compression Anastomosis Ring (CAR) for Compression Anastomosis in Anterior Resection

NCT00468416

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

May 4, 2007Estimated

Enrollment

Phase

Phase 2

Conditions

Colorectal Cancer

Interventions

Compression Anastomosis Ring (CAR)

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Not provided

Completion Date

Feb 2008

First Submitted Date

May 1, 2007

First Submission Date that Met QC Criteria

May 1, 2007

First Posted Date

May 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2007

Last Update Posted Date

May 4, 2007Estimated

Name	Class
Rabin Medical Center	OTHER
Kaplan Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the NiTi CAR device in the creation of colorectal anastomosis

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Compression Anastomosis Ring (CAR)	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functioning anastomosis and no occurrence of adverse events related to device use		During hospitalization and one month post procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient age over 18 years
Patient scheduled for colorectal cancer surgery
Patient is able to comprehend and sign the Informed Consent Form

Exclusion Criteria:

Patient has known allergy to nickel
Patient with bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection
Patients who are participating in another trial
Patient on regular steroid medication
Patients who are undergoing a stoma
Patients with contraindications to general anesthesia
Patient with preexisting sphincter problems or evidence of extensive local disease in the pelvis
Patients after radiation
Patients who refuse consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hagit Tulchinsky, M.D.	Contact	+972-3-6973315	3315	hagitt@tasmc.health.gov.il

Overall Officials

Name	Affiliation	Role
Hagit Tulchinsky, M.D.	Tel-Aviv Sourasky Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tel Aviv Sourasky Medical Center	Recruiting	Tel Aviv			Israel

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided