Thoracic CancerNCT05143541

Use of a New Stapling Device in General Thoracic Surgery

An observational study of Thoracic Cancer, run by Lexington Medical Inc. at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Thoracic Cancer
What is being tested?: AEON Endostapler
Type of treatment: Medical device
How many people: 80 participants
Where: 1 siteSwitzerland
Study dates: 1 Mar 2021to 30 Sep 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 80 subjects meeting inclusion criteria

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Kantonsspital St. Gallen
Sankt Gallen, 9001

Other trials in Switzerland

About this study

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

Read the 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.

Conditions: Thoracic Cancer
Being tested: AEON Endostapler

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AEON EndostaplerDevice
Surgery with AEON Endostapler

Study groups in NCT05143541
Study group	Role	What they receive
AEON Endostapler		Stapling performed with AEON Endostapler Receives: Device: AEON Endostapler

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Product Malfunction
Number of participants with product malfunction. Product malfunction means any occurrence during the surgery where the stapler does not perform as intended.
Measured: Within surgery, up to 8 hours
Number of Participants With Intraoperative Staple Line Bleeding
Number of participants with intraoperative staple line bleeding
Measured: Within surgery, up to 8 hours
Number of Participants With Reported Device-related Adverse Events
Number of participants with reported device-related adverse events
Measured: Within 30-day post-operative period

Secondary outcomes (2)

Hospital Length of Stay
Hospital length of stay (days)
Measured: Following hospital admission, up to discharge
Chest Tube Removal
Time before chest tube removal (days)
Measured: Following surgery, up to chest tube removal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202130 Sep 2021

First posted3 Dec 2021
Study start1 Mar 2021
Primary completion30 Sep 2021
Study completion30 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Thoracic CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05143541
Sponsor's protocol ID: Endostapler04
Status last verified: Nov 2021
First submitted: 10 Nov 2021
Last updated: 29 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Thoracic Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of a New Stapling Device in General Thoracic Surgery
ClinicalTrials.gov ID: NCT05143541
Acronym / sponsor ID: Endostapler04
Conditions: Thoracic Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Lexington Medical Inc.Industry (pharma, biotech, devices)
Study start: 1 Mar 2021 (actual)
Primary completion: 30 Sep 2021 (actual)
Study completion: 30 Sep 2021 (actual)
First posted: 3 Dec 2021 (actual)
Results: Posted 21 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
AEON Endostapler	–	Device: AEON EndostaplerStapling performed with AEON Endostapler

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 80 subjects meeting inclusion criteria

Key inclusion criteria (1 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AEON EndostaplerSurgery with AEON Endostapler	Device	AEON Endostapler

Primary outcome

Number of Participants With Product Malfunction
Time frame: 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.
Number of Participants With Intraoperative Staple Line Bleeding
Time frame: Within surgery, up to 8 hours
Number of participants with intraoperative staple line bleeding
Number of Participants With Reported Device-related Adverse Events
Time frame: Within 30-day post-operative period
Number of participants with reported device-related adverse events

2 secondary outcomes

Hospital Length of Stay
Time frame: Following hospital admission, up to discharge
Chest Tube Removal
Time frame: Following surgery, up to chest tube removal

Results and safety

Results posted to the registry on 21 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AEON Endostapler	80	80

Primary outcome: Number of Participants With Product Malfunction

Time frame: Within surgery, up to 8 hours. Count of participants. Unit: Participants

Measure	AEON Endostapler n = 80
Value	0

Primary outcome: Number of Participants With Intraoperative Staple Line Bleeding

Time frame: Within surgery, up to 8 hours. Count of participants. Unit: Participants

Measure	AEON Endostapler n = 80
Value	0

Primary outcome: Number of Participants With Reported Device-related Adverse Events

Time frame: Within 30-day post-operative period. Count of participants. Unit: Participants

Measure	AEON Endostapler n = 80
Value	0

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AEON Endostapler	0 of 80 (0%)	0 of 80 (0%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Thoracic Cancer

RecruitingEarly Phase 1
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Lung Adenocarcinoma, Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2/3
A Randomized Trial of Standard vs. Hypofractionated Accelerated Radiotherapy for Progression in Limited-Stage Small Cell Lung Cancer
Limited Stage Small-Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Thoracic Cancer, run by Lexington Medical Inc. at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Product Malfunction (time frame: Within surgery, up to 8 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05143541.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.