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Use of a New Stapling Device in General Thoracic Surgery

NCT ID: NCT05143541

Last Updated: 2022-12-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-09-30

Brief Summary

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

Detailed Description

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

Conditions

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Thoracic Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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AEON Endostapler

Stapling performed with AEON Endostapler

AEON Endostapler

Intervention Type DEVICE

Surgery with AEON Endostapler

Interventions

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AEON Endostapler

Surgery with AEON Endostapler

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lexington Medical Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Site Status

Countries

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Switzerland

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Endostapler04

Identifier Type: -

Identifier Source: org_study_id