Use of a New Stapling Device in General Thoracic Surgery

NCT05143541 | Completed Results FDA Device

• 1 other identifier: Endostapler04
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thoracic Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  Within surgery, up to 8 hours

• Number of Participants With Intraoperative Staple Line Bleeding

  Number of participants with intraoperative staple line bleeding

  Within surgery, up to 8 hours

• Number of Participants With Reported Device-related Adverse Events

  Number of participants with reported device-related adverse events

  Within 30-day post-operative period

Secondary Outcomes (2)

• Hospital Length of Stay

  Following hospital admission, up to discharge

• Chest Tube Removal

  Following surgery, up to chest tube removal

Study Arms (1)

AEON Endostapler

Stapling performed with AEON Endostapler

Device: AEON Endostapler

Interventions

AEON Endostapler DEVICE

Surgery with AEON Endostapler

AEON Endostapler

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

80 subjects meeting inclusion criteria

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lexington Medical Inc.: lead

Study Sites (1)

Kantonsspital St. Gallen

Sankt Gallen, 9001, Switzerland

Location

Results Point of Contact

• Title: Dr. André E. Dutly
• Organization: Kantonsspital St. Gallen

andre.dutly@kssg.ch

071 494 9944

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 3, 2021
• Study Start: March 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: December 29, 2022
• Results First Posted: January 21, 2022

Record last verified: 2021-11

Locations

CH (1)