Xpan Non-Inferiority Study

West Virginia University

Status: Not yet enrolling

Conditions: Bariatric Surgery Candidate

Treatments: Device: Xpan Trocar System; Device: Standard of Care (Non-expanding Trocar)

Study type: Interventional

Funder types: Other

Identifiers

NCT07385690

2506178705

Details and patient eligibility

About

A trocar is a surgical instrument with a sharp point and tube and is used to create endoscopic access in the abdomen or chest where endoscopic instruments can be entered & used in minimally invasive surgical procedures. Xpan has created an FDA Cleared radially dilating trocar (RDT) that is inserted at 3mm and can be expanded to 5mm or 12mm during surgery. The purpose of this research protocol is to demonstrate that a new FDA Cleared Xpan® radially dilating trocar (RDT) system is at least, just as effective as the existing RDT trocar systems. The procedure will be performed using a radially dilating trocar that is inserted at 3mm and can be expanded to 5mm or 12mm during surgery.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals scheduled for the following procedures:

  • Sleeve Gastrectomy
  • Bypass
  • Revision & other bariatric procedures
  • Robotic procedures
  • Bariatric patients

Exclusion criteria

• Any individual not scheduled for the above procedure and/or does not meet the age requirments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups, including a placebo group

Xpan Trocar System

Active Comparator group

Description:

Participants will undergo laparoscopic surgery using the Xpan Trocar System. Standard insertion technique will be used to create a 3 mm punch into an already gas-extended abdomen. A total of 3-5 trocars will be placed based on the type of surgery. Once placed, trocars will be radially dilated to the size necessary for the procedure, generally 2 trocars expanded to 5 mm and 2 trocars expanded to 12 mm. Final trocar size will range from 3 mm to 12 mm. Both placement and final dilated size will be documented.

Treatment:

Device: Xpan Trocar System

Standard of Care (Non-expanding Trocar)

Placebo Comparator group

Description:

Participants will undergo laparoscopic surgery using a non-expanding trocar, which is considered the institutions standard of care for the procedure. Trocar size is selected based on surgical requirements and remain fixed throughout the procedure.

Treatment:

Device: Standard of Care (Non-expanding Trocar)