Use of a New Stapling Device in General Thoracic Surgery

• Sponsor: Lexington Medical Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05143541
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Actual Duration (Months): 7
• Patients Per Site Per Month: 11.4

Study Details

Study Description

Brief Summary

The goal of this study was to test the safety and efficacy of this stapler in our general thoracic surgery practice.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Cancer	Device: AEON Endostapler

Detailed Description

A prospective study was conducted with 80 consecutive thoracic cases. Stapler usage data, intraoperative outcomes, and 30-day post-operative outcomes were evaluated.

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Use of a New Stapling Device in General Thoracic Surgery
• Actual Study Start Date: Mar 1, 2021
• Actual Primary Completion Date: Sep 30, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
AEON Endostapler Stapling performed with AEON Endostapler	Device: AEON Endostapler; Surgery with AEON Endostapler

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Product Malfunction [Within surgery]

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

2. Number of Participants With Intraoperative Staple Line Bleeding [Within surgery]

   Number of participants with intraoperative staple line bleeding

3. Number of Participants With Reported Device-related Adverse Events [Within 30-day post-operative period]

   Number of participants with reported device-related adverse events

Secondary Outcome Measures

1. Hospital Length of Stay [Immediately after hospital admission]

   Hospital length of stay (days)

2. Chest Tube Removal [Immediately after surgery]

   Time before chest tube removal (days)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients undergoing planned VATS or open lung resection surgery (lobectomy or wedge resection)

Exclusion Criteria:

• Active bacterial or fungal infection

• Prior history of VATS or open lung surgery

• Use of staple line reinforcement material (buttress)

• Patients under the age of 18 on the date of the surgery

• Any female patient who is pregnant

• Scheduled concurrent surgical procedure other than lobectomy or wedge resection (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kantonsspital St. Gallen	St. Gallen		Switzerland	9001

Sponsors and Collaborators

• Lexington Medical Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 21, 2021

More Information

Publications

None provided.

• Responsible Party: Lexington Medical Inc.
• ClinicalTrials.gov Identifier: NCT05143541
• Other Study ID Numbers: Endostapler04
• First Posted: Dec 3, 2021
• Last Update Posted: Jan 21, 2022
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Aneurysm, Dissecting

Study Results

Participant Flow

Arm/Group Title	AEON Endostapler
Arm/Group Description	Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler
Period Title: Overall Study
STARTED	80
COMPLETED	80
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	AEON Endostapler
Arm/Group Description	Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler
Overall Participants	80
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.8 (12.5)
Sex: Female, Male (Count of Participants)
Female	38 47.5%
Male	42 52.5%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Product Malfunction
Description	Number of participants with product malfunction. Product malfunction means any occurrence during the surgery where the stapler does not perform as intended.
Time Frame	Within surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AEON Endostapler
Arm/Group Description	Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler
Measure Participants	80
Count of Participants [Participants]	0 0%

2. Primary Outcome

Title	Number of Participants With Intraoperative Staple Line Bleeding
Description	Number of participants with intraoperative staple line bleeding
Time Frame	Within surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AEON Endostapler
Arm/Group Description	Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler
Measure Participants	80
Count of Participants [Participants]	0 0%

3. Primary Outcome

Title	Number of Participants With Reported Device-related Adverse Events
Description	Number of participants with reported device-related adverse events
Time Frame	Within 30-day post-operative period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AEON Endostapler
Arm/Group Description	Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler
Measure Participants	80
Count of Participants [Participants]	0 0%

4. Secondary Outcome

Title	Hospital Length of Stay
Description	Hospital length of stay (days)
Time Frame	Immediately after hospital admission

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AEON Endostapler
Arm/Group Description	Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler
Measure Participants	80
Mean (Standard Deviation) [days]	3.8 (3.2)

5. Secondary Outcome

Title	Chest Tube Removal
Description	Time before chest tube removal (days)
Time Frame	Immediately after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AEON Endostapler
Arm/Group Description	Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler
Measure Participants	80
Mean (Standard Deviation) [days]	2.1 (2.7)

Adverse Events

Time Frame	30 days
Arm/Group Title	AEON Endostapler
Arm/Group Description	Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler
All Cause Mortality
	AEON Endostapler
	Affected / at Risk (%)	# Events
Total	0/80 (0%)
Serious Adverse Events
	AEON Endostapler
	Affected / at Risk (%)	# Events
Total	0/80 (0%)
Other (Not Including Serious) Adverse Events
	AEON Endostapler
	Affected / at Risk (%)	# Events
Total	0/80 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.