Trial Outcomes & Findings for Use of a New Stapling Device in General Thoracic Surgery (NCT NCT05143541)

Results Overview

Number of participants with product malfunction. Product malfunction means any occurrence during the surgery where the stapler does not perform as intended.

Recruitment status

COMPLETED

Target enrollment

80 participants

Primary outcome timeframe

Within surgery, up to 8 hours

Results posted on

2022-12-29

Participant Flow

Participant milestones

Participant milestones
Measure	AEON Endostapler Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler
Overall Study STARTED	80
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AEON Endostapler n=80 Participants Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler
Age, Continuous	64.8 years STANDARD_DEVIATION 12.5 • n=80 Participants
Sex: Female, Male Female	38 Participants n=80 Participants
Sex: Female, Male Male	42 Participants n=80 Participants

PRIMARY outcome

Timeframe: Within surgery, up to 8 hours

Number of participants with product malfunction. Product malfunction means any occurrence during the surgery where the stapler does not perform as intended.

Outcome measures

Outcome measures
Measure	AEON Endostapler n=80 Participants Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler
Number of Participants With Product Malfunction	0 Participants

PRIMARY outcome

Timeframe: Within surgery, up to 8 hours

Number of participants with intraoperative staple line bleeding

Outcome measures

Outcome measures
Measure	AEON Endostapler n=80 Participants Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler
Number of Participants With Intraoperative Staple Line Bleeding	0 Participants

PRIMARY outcome

Timeframe: Within 30-day post-operative period

Number of participants with reported device-related adverse events

Outcome measures

Outcome measures
Measure	AEON Endostapler n=80 Participants Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler
Number of Participants With Reported Device-related Adverse Events	0 Participants

SECONDARY outcome

Timeframe: Following hospital admission, up to discharge

Hospital length of stay (days)

Outcome measures

Outcome measures
Measure	AEON Endostapler n=80 Participants Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler
Hospital Length of Stay	3.8 days Standard Deviation 3.2

SECONDARY outcome

Timeframe: Following surgery, up to chest tube removal

Time before chest tube removal (days)

Outcome measures

Outcome measures
Measure	AEON Endostapler n=80 Participants Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler
Chest Tube Removal	2.1 days Standard Deviation 2.7

Adverse Events

AEON Endostapler

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

Dr. André E. Dutly

Kantonsspital St. Gallen

Phone: 071 494 9944

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place