Trial Outcomes & Findings for Apollo Overstitch, a Treat and Resect Model (NCT NCT01307813)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Approximately 1 hour post resection of the colon in surgery

Results posted on

2022-02-24

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Apollo Overstitch, a Treat and Resect Model

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Endoscopic Suturing Device n=4 Participants 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
Age, Continuous	54.8 years STANDARD_DEVIATION 9.73 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 1 hour post resection of the colon in surgery

Population: Participants who received Overstitch.

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).

Outcome measures

Outcome measures
Measure	Endoscopic Suturing Device n=4 Participants 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.
Successful Suture Approximation With Cinching Device	3.57 score on a scale Standard Deviation 0.72

PRIMARY outcome

Timeframe: Approximately 1 hour post resection of the colon in surgery

Population: Participants who received Overstitch when two tissue bites were taken within an individual stitch.

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).

Outcome measures

Outcome measures
Measure	Endoscopic Suturing Device n=3 Participants 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.
Successful Suture Approximation With Cinching Device	2.66 score on a scale Standard Deviation 0.94

Adverse Events

Endoscopic Suturing Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey Marks, MD - General Surgeon

University Hospitals Cleveland Medical Center

Phone: 216-983-4930

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place