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| Name | Class |
|---|---|
| Apollo Endosurgery, Inc. | INDUSTRY |
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The Overstitch (Apollo Endosurgery, Austin, Texas) is an FDA cleared product which attaches to a standard double channel endoscope. The Overstitch can place sutures under endoscopic guidance, with the goal of reproducing standard surgical techniques. These would include hemostasis, tissue approximation, anastomosis formation, fixation of intraluminal devices, or repair/closure of mucosal or full thickness defects such as perforations or endoscopic mucosal resection (EMR) sites. Knot tying of the endoscopically placed sutures is provided by an endoscopic cinching device that passes through the channel of the endoscope.
This feasibility trial will evaluate the ability of the Apollo suturing device (Overstitch) to endoscopically place sutures into normal mucosa, and then "tie" the sutures with the cinching device. These devices have been utilized effectively in explant, live porcine, and human cadaver colon and stomach models. In this treat and resect model, sutures would be placed in a segment of colon or stomach that is being surgically removed via open or laparoscopic technique for the treatment of benign or malignant disease. The sutures would be placed in a segment of normal mucosa remote to the pathology being surgically treated. In addition, the sutures will be placed under direct observation via laparoscopic or open visualization. After resection of the segment of colon, it will be evaluated grossly for level of suture placement, evidence of perforation, and quality of suture approximation with the cinching device.
During the colectomy procedure, the intended proximal and distal margins of resection will be determined, and the protocol will proceed only if it is fully determined that the tissue will be fully resectable. The overstitch device affixed to a standard double channel gastroscope will then be advanced transanally into the segment of planned resected colon, away from the area of disease so as to not interfere with oncologic principles or post-resection pathologic evaluation. Endoscopic sutures and knot tying cinching elements will be placed, with a limit of 15 minutes for the total procedure. The entire procedure will be closely monitored under laparoscopic or open surgical visualization. After suture placement, the surgical resection will continue as planned. The specimen will then be examined for depth of suture placement, evidence of perforation, and quality of the suture approximation with the knot tying element.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic suturing device | Experimental | Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Overstitch Endoscopic Suturing System | Device | Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area. Patients will already require resection of segments of colon for treatment of benign or malignant disease and this will therefore be a treat and resect model |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Suture Approximation With Cinching Device | Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area. The quality of cinch element effectiveness was graded on a four-point Likert scale (1 = Poor, 2 = Good, 3 = Very Good, 4 = Excellent). | Approximately 1 hour post resection of the colon in surgery |
| Successful Suture Approximation With Cinching Device | Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area. When two tissue bites were taken within an individual stitch, the quality of mucosal approximation was graded on a four-point Likert scale (1 = Poor, 2 = Good, 3 = Very Good, 4 = Excellent). | Approximately 1 hour post resection of the colon in surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Marks, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Endoscopic Suturing Device | Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area. Overstitch Endoscopic Suturing System: Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area. Patients will already require resection of segments of colon for treatment of benign or malignant disease and this will therefore be a treat and resect model |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Endoscopic Suturing Device | Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area. Overstitch Endoscopic Suturing System: Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area. Patients will already require resection of segments of colon for treatment of benign or malignant disease and this will therefore be a treat and resect model |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Successful Suture Approximation With Cinching Device | Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area. The quality of cinch element effectiveness was graded on a four-point Likert scale (1 = Poor, 2 = Good, 3 = Very Good, 4 = Excellent). | Participants who received Overstitch. | Posted | Mean | Standard Deviation | score on a scale | Approximately 1 hour post resection of the colon in surgery |
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Adverse intra-operative and post-operative events approximately 1 hour post resection of the colon in surgery were noted.
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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 | Endoscopic Suturing Device | Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area. Overstitch Endoscopic Suturing System: Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area. Patients will already require resection of segments of colon for treatment of benign or malignant disease and this will therefore be a treat and resect model |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Marks, MD - General Surgeon | University Hospitals Cleveland Medical Center | 216-983-4930 | Jeffrey.Marks@uhhospitals.org |
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| Primary | Successful Suture Approximation With Cinching Device | Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area. When two tissue bites were taken within an individual stitch, the quality of mucosal approximation was graded on a four-point Likert scale (1 = Poor, 2 = Good, 3 = Very Good, 4 = Excellent). | Participants who received Overstitch when two tissue bites were taken within an individual stitch. | Posted | Mean | Standard Deviation | score on a scale | Approximately 1 hour post resection of the colon in surgery |
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| 4 |
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| 4 |
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