Clinical trial NCT04544865: Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement
Official title: A Prospective, Single-Arm, Multi-Center Study of the ECHELON ENDOPATH(TM) Staple Line Reinforcement Device in Gastric and Lung Resection Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Procedures
Lung Resection Procedures
Keywords: Buttress, gastrectomy, gastric bypass, lung volume reduction
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2020-09-10
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective, single-arm, multi-center evaluation will collect clinical data in a post-market setting. The two types of procedures studied will be gastric and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ECHELON ENDOPATH Staple Line Reinforcement instructions for use.

Detailed description: The primary objective of this study is to prospectively generate clinical data on device-related adverse events in a post-market setting using ECHELON ENDOPATH Staple Line Reinforcement per its instructions for use. There will be no blinding in this study. An interim analysis is planned for sample-size re-estimation.

Eligibility criteria: Inclusion Criteria:

* Primary procedure (gastric or lung resection) where the ECHELON SLR is planned to be used for reinforcement of staple lines per the IFU in either a or b:

  1. Gastric procedures limited to laparoscopic gastric resection, robotic laparoscopic gastric resection, partial gastrectomy, gastric wedge resection, subtotal gastrectomy, laparoscopic Roux-en-Y gastric bypass, and robotic laparoscopic gastric bypass; or
  2. Lung resection procedures that include lobectomy, segmentectomy or wedge resection, and lung volume reduction surgery, and may be video assisted thoracic surgery (VATS) or open procedures;
* Willingness to give consent and comply with all study-related evaluations and visit schedule; and
* At least 18 years of age.

Exclusion Criteria:

- Preoperative:

1. Physical or psychological condition which would impair study participation;
2. Body mass index (BMI) ≥ 46.0 kg/m2;
3. The procedure is a revision/reoperation for the same indication or same anatomical location;
4. A procedure where extended wound or organ support is required;
5. Any medical condition that the investigator deems could impact inflammatory or immune response;
6. Concurrent treatment with medications that the investigator deems could have influence on wound healing;
7. History of hypersensitivity to polyglactin (Vicryl®), Polydioxanone (PDO or PDS), or hypersensitivity to related products (cross-allergy); or
8. Enrollment in a concurrent interventional clinical study that could impact the study endpoints.

   * Intraoperative:
9. Per surgeon discretion, presence of adhesions that could lead to an increased risk of leak occurrence at a different location than the staple line.

Primary outcomes:
measure: Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures
timeFrame: From Day 0 (day of surgery) through 70 days post-surgery
measure: Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days
timeFrame: From Day 0 (day of surgery) through 70 days post-surgery
Secondary outcomes:
measure: Number of Study Devices Replaced During Surgery
timeFrame: Day 0 (Intra-surgery)
measure: Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback
timeFrame: Day 0 (Intra-surgery)
measure: Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback
timeFrame: Day 0 (Intra-surgery)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: New York
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Henry Ford Health System
name: Andrew Popoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Long Island Jewish Medical Center
name: David Zeltsman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Missouri-Columbia
name: Andrew Wheeler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spectrum Health Hospitals
name: Jon Schram, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University Health
name: Kenneth Kesler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Our Lady of the Lake Hospital
name: Emily Cassidy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Keith Gersin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Linda Martin, MD
role: PRINCIPAL_INVESTIGATOR
References: