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| Name | Class |
|---|---|
| Atlanta Colon & Rectal Surgery, Atlanta, GA | OTHER |
| FPMG Center for Colon & Rectal Surgery | UNKNOWN |
| Lester E. Cox Medical Centers | OTHER |
| UCI Medical Center Irvine CA |
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The performance of the ColonRingâ„¢ will be comparable to or better than the reported performance of staplers.
The proposed study is a post marketing study intended to gather and record additional data to further evaluate the performance of the ColonRingâ„¢ device in regards to the creation of a colorectal anastomosis.
The study objective is to evaluate the performance of the ColonRingâ„¢ in the creation of a circular anastomosis in colorectal procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ColonRing TM | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ColonRing (Colorectal anastomosis) | Device | Creation of a colorectal compression anastomosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRingâ„¢ Device, at 1 Month | Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device. | Approx. 1 year |
| Device Related Leak Rate up to 30 Days Post op | Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device. | 30 days post op |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure. | The post operative parameters that will be measured during hospitalization period:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eran Choman, Msc | novoGI | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCI Medical Center | Irvine | California | United States | |||
| University of Southern California Health Sciences Campus |
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| Label | URL |
|---|---|
| Click here for more information about study device (sponsor's web site) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | ColonRing TM | ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| UNKNOWN |
| Endeavor Health | OTHER |
| St.Louis University hospital MO | UNKNOWN |
| University of Southern California | OTHER |
| Bnai Zion Medical Center | OTHER_GOV |
| Barmherzig Brueder | UNKNOWN |
| Catharina Ziekenhuis Eindhoven | OTHER |
| Ziekenhuis Oost-Limburg | OTHER |
| University Hospital, Gasthuisberg | OTHER |
| Klinikum Neuperlach | UNKNOWN |
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| 30 days post op |
| Los Angeles |
| California |
| United States |
| FPMG Center for Colon & Rectal Surgery | Orlando | Florida | 32804 | United States |
| Southern Regional Medical Center | Riverdale | Georgia | United States |
| NorthShore University Health System | Evanston | Illinois | United States |
| Lester E. Cox Medical Center | Springfield | Missouri | United States |
| St. Louis University Hospital | St Louis | Missouri | United States |
| KH Barmherzig Brueder | Vienna | A-1020 | Austria |
| Ziekenhuis Oost Limburg | Genk | 3600 | Belgium |
| University Hospital Gasthuisberg | Leuven | 3000 | Belgium |
| Klinikum Neuperlach | Munich | 81737 | Germany |
| Bnai Zion Medical Center | Haifa | 31048 | Israel |
| Catharina Ziekenhuis | Eindhoven | 5623EJ | Netherlands |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ColonRing TM | ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRingâ„¢ Device, at 1 Month | Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device. | Not Posted | Approx. 1 year | ||||||||||||||||||||
| Secondary | Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure. | The post operative parameters that will be measured during hospitalization period:
| Not Posted | 30 days post op | ||||||||||||||||||||
| Primary | Device Related Leak Rate up to 30 Days Post op | Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device. | Posted | Number | participants | 30 days post op |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ColonRing TM | ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis | 26 | 279 | 0 | 279 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leak | Surgical and medical procedures |
| |||
| Abscess | Surgical and medical procedures |
| |||
| Fistula | Surgical and medical procedures |
|
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The study had acceptable rate of AE, and technical problems.
14.1 Review. Institution may publish the results of the Study, based on information collected or generated by Institution and Principal Investigator within the framework thereof, subject to the provisions of this section. In any event, however, no publication, presentation in any forum or any other form of disclosure with respect to the Study or the results thereof will be made prior to the publication of the Joint Publication without Sponsor's prior written consent.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eran Choman, VP Clinical Affairs & Statistics | novoGI | +972 9 8603000 | eran.choman@novogi.com |
| Austria |
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| Israel |
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| Germany |
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| Netherlands |
|
|