Trial Outcomes & Findings for Endostapler Hemostasis Study (NCT NCT04149925)

NCT ID: NCT04149925

Last Updated: 2021-02-23

Results Overview

Intraoperative staple line bleeding as measured by the provided bleeding severity scale (1: No bleeding; 2: Minimal bleeding; 3: Moderate bleeding; 4: Excessive bleeding; 5: Profuse bleeding)

• Recruitment status: COMPLETED
• Target enrollment: 60 participants
• Primary outcome timeframe: 10 seconds after last staple line
• Results posted on: 2021-02-23

Participant Flow

Participant milestones

Measure	AEON Endostapler Stapling performed by AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler	Echelon Flex Powered Stapler Stapling performed by Echelon Flex Powered Stapler Echelon Flex Powered Stapler: Surgery with Echelon Flex Powered Stapler
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	AEON Endostapler n=30 Participants Stapling performed by AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler	Echelon Flex Powered Stapler n=30 Participants Stapling performed by Echelon Flex Powered Stapler Echelon Flex Powered Stapler: Surgery with Echelon Flex Powered Stapler	Total n=60 Participants Total of all reporting groups
Age, Continuous	46 years STANDARD_DEVIATION 11 • n=30 Participants	45 years STANDARD_DEVIATION 11 • n=30 Participants	46 years STANDARD_DEVIATION 11 • n=60 Participants
Sex: Female, Male Female	18 Participants n=30 Participants	25 Participants n=30 Participants	43 Participants n=60 Participants
Sex: Female, Male Male	12 Participants n=30 Participants	5 Participants n=30 Participants	17 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	44 kg/m^2 STANDARD_DEVIATION 6 • n=30 Participants	46 kg/m^2 STANDARD_DEVIATION 7 • n=30 Participants	45 kg/m^2 STANDARD_DEVIATION 7 • n=60 Participants

PRIMARY outcome

Timeframe: 10 seconds after last staple line

Intraoperative staple line bleeding as measured by the provided bleeding severity scale (1: No bleeding; 2: Minimal bleeding; 3: Moderate bleeding; 4: Excessive bleeding; 5: Profuse bleeding)

Outcome measures

Measure	AEON Endostapler n=30 Participants Stapling performed by AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler	Echelon Flex Powered Stapler n=30 Participants Stapling performed by Echelon Flex Powered Stapler Echelon Flex Powered Stapler: Surgery with Echelon Flex Powered Stapler
Staple Line Bleeding	2.08 score on a scale Standard Deviation .98	2.57 score on a scale Standard Deviation 1.13

SECONDARY outcome

Timeframe: 1 month following procedure

Incidence of postoperative leakage during one-month monitoring period following procedure

Outcome measures

Measure	AEON Endostapler n=30 Participants Stapling performed by AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler	Echelon Flex Powered Stapler n=30 Participants Stapling performed by Echelon Flex Powered Stapler Echelon Flex Powered Stapler: Surgery with Echelon Flex Powered Stapler
Staple Line Leaking Yes	0 Participants	0 Participants
Staple Line Leaking No	30 Participants	30 Participants

SECONDARY outcome

Timeframe: 1 month following procedure

Incidence of reported device-related adverse events

Outcome measures

Measure	AEON Endostapler n=30 Participants Stapling performed by AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler	Echelon Flex Powered Stapler n=30 Participants Stapling performed by Echelon Flex Powered Stapler Echelon Flex Powered Stapler: Surgery with Echelon Flex Powered Stapler
Adverse Events Yes	0 Participants	0 Participants
Adverse Events No	30 Participants	30 Participants

SECONDARY outcome

Timeframe: During surgery

Incidence of product malfunction during procedure

Outcome measures

Measure	AEON Endostapler n=30 Participants Stapling performed by AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler	Echelon Flex Powered Stapler n=30 Participants Stapling performed by Echelon Flex Powered Stapler Echelon Flex Powered Stapler: Surgery with Echelon Flex Powered Stapler
Product Malfunction Yes	0 Participants	0 Participants
Product Malfunction No	30 Participants	30 Participants

SECONDARY outcome

Timeframe: Within 72 hours of surgery start

Incidence of intraoperative or postoperative blood transfusion within 72 hours of surgery start time

Outcome measures

Measure	AEON Endostapler n=30 Participants Stapling performed by AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler	Echelon Flex Powered Stapler n=30 Participants Stapling performed by Echelon Flex Powered Stapler Echelon Flex Powered Stapler: Surgery with Echelon Flex Powered Stapler
Blood Transfusion Yes	0 Participants	0 Participants
Blood Transfusion No	30 Participants	30 Participants

SECONDARY outcome

Timeframe: 1 week following procedure

Postoperative pain level as measured by a standard pain severity scale of 0-10 where 0 means no pain and 10 means severe pain.

Outcome measures

Measure	AEON Endostapler n=30 Participants Stapling performed by AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler	Echelon Flex Powered Stapler n=30 Participants Stapling performed by Echelon Flex Powered Stapler Echelon Flex Powered Stapler: Surgery with Echelon Flex Powered Stapler
Pain Level	1.8 score on a scale Standard Deviation 2.9	1.6 score on a scale Standard Deviation 2.7

Adverse Events

AEON Endostapler

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Echelon Flex Powered Stapler

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

Annette Dunn

Lexington Medical Inc.

Phone: 480-313-8505

Email: annette@lexington-med.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place