View Clinical Trial (Medical Research Study)
a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™
| City: |
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Riverdale |
| State: |
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Georgia |
| Zip Code: |
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30274 |
| Conditions: |
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Diverticulum, Colon - Colorectal Neoplasms - Crohn Disease - Colitis, Ulcerative - Colostomy - Ileostomy - Stoma - Rectal Prolapse - Intestinal Polyposis - Lymphoma - Endometriosis - Intestinal Volvulus |
| Purpose: |
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The proposed study is a post marketing, observational, retrospective data collection
intended to gather and record data on patients treated with the ColonRing™ device in routine
clinical practice at a single center. The data will assist in further evaluating the
performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis.
Hypothesis:The performance of the ColonRing™, determined by the rate of complications, will
be within the acceptable range reported in the literature for alternative treatment
modalities.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Patient was > 18 years old at time of procedure
- Patient underwent an open or laparoscopic colorectal procedure with the creation of
an anastomosis using the ColonRing™
- Patient treated in routine clinical practice following marketing clearance of the
device within the cleared intended use
- Patient underwent his/her first follow-up visit within two months post-surgery
Exclusion Criteria:
- No exclusion criteria have been defined for this data collection.
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| NCT ID: |
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NCT01301417 |
| Primary Contact: |
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Study Director
Yael Nir, MD
NiTi Surgical Solutions Ltd.
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| Backup Contact: |
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N/A |
| Location Contact: |
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Riverdale, Georgia 30274
United States
Stephen Cohen, MD
Phone: 770-997-1975
Email: stephencohen615@gmail.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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