Gastric ProceduresNCT04544865

Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement

A study testing Staple Line Reinforcement in people with Gastric Procedures and Lung Resection Procedures, run by Ethicon Endo-Surgery at 8 sites in United States.

Completed

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

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastric Procedures, Lung Resection Procedures
What is being tested?: Staple Line Reinforcement
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 8 sitesUnited States
Study dates: 29 Sep 2020to 8 Feb 2023
Phase: Interventional
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

Who may be able to join

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:
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
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.

Who cannot join

Preoperative:
Physical or psychological condition which would impair study participation;
Body mass index (BMI) ≥ 46.0 kg/m2;
The procedure is a revision/reoperation for the same indication or same anatomical location;
A procedure where extended wound or organ support is required;
Any medical condition that the investigator deems could impact inflammatory or immune response;

Show all 11Show fewer

Concurrent treatment with medications that the investigator deems could have influence on wound healing;
History of hypersensitivity to polyglactin (Vicryl®), Polydioxanone (PDO or PDS), or hypersensitivity to related products (cross-allergy); or
Enrollment in a concurrent interventional clinical study that could impact the study endpoints.
Intraoperative:
Per surgeon discretion, presence of adhesions that could lead to an increased risk of leak occurrence at a different location than the staple line.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
Atrium Health
Charlotte, North Carolina, 28203
University of Virginia
Charlottesville, Virginia, 22908
University of Missouri
Columbia, Missouri, 65201
Henry Ford Health System
Detroit, Michigan, 48202
Spectrum Health
Grand Rapids, Michigan, 49503
Indiana University Health
Indianapolis, Indiana, 46202
Long Island Jewish Medical Center
New York, New York, 11040

Other trials in United States

About this study

Official title: A Prospective, Single-Arm, Multi-Center Study of the ECHELON ENDOPATH(TM) Staple Line Reinforcement Device in Gastric and Lung Resection Procedures

Read the 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.

Conditions: Gastric Procedures, Lung Resection Procedures
Being tested: Staple Line Reinforcement
Keywords: Buttress, gastrectomy, gastric bypass, lung volume reduction

What participants receive

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

Staple Line ReinforcementDevice
ENDOPATH ECHELON Staple Line Reinforcement is used for reinforcement of staple lines during lung resection and bariatric surgical procedures, according to instructions for use.

Study groups in NCT04544865
Study group	Role	What they receive
Gastric and thoracic staple line reinforcement	Experimental	ECHELON ENDOPATH Staple Line Reinforcement is used during a gastric or thoracic procedure. Receives: Device: Staple Line Reinforcement

What is being measured

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

Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures
Number of participants who experienced specific device-related AEs post gastric resection procedures was reported. Specific device-related AEs were bleeding (defined as occurrence of post-surgery blood transfusion deemed related to bleeding at the staple line or return to surgery room before 70-day post-surgery follow-up visit due to bleeding deemed related to the staple line), leak (defined as occurrence of intra-surgery or post-surgery gastrointestinal leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically), and stricture (defined as occurrence of stricture documented radiographically or by endoscopy along the staple line).
Measured: From Day 0 (day of surgery) through 70 days post-surgery
Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days
Number of participants who experienced specific device-related AEs post lung resection procedures was reported. Specific device related AEs were prolonged air leak (occurrence of intra-surgery or post-surgery lung leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically) deemed related to the staple line (greater than post-surgery Day 7), and empyema (defined as purulent fluid collection in the pleural space documented radiographically, excluding chronic empyema).
Measured: From Day 0 (day of surgery) through 70 days post-surgery

Secondary outcomes (3)

Number of Study Devices Replaced During Surgery
Number of study devices replaced during surgery due to slipping or bunching or not properly loaded onto stapler cartridge, Other - preloaded wrong color cartridge, Other- SLR added before cartridge, Other- dropped on the ground was reported.
Measured: Day 0 (Intra-surgery)
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback
Investigators were asked to answer a non-validated device questionnaire related to his/her experience using the ECHELON SLR. Questionnaire included following questions "experienced less manipulation or movement compared to previous device, experienced greater confidence the device will deliver best result compared to previous device, experienced greater confidence in simplicity of set up compared to previous device, experienced less frustration with device compared to previous device, experienced less waste compared to previous device, Likely to recommend to a colleague. Each question response was ranged from 1 to 5 where 1=strongly disagree, 2=slightly disagree,3=neutral, 4=slightly agree, 5= strongly agree, where the higher response signified good experience on the device. In this outcome measure, device questionnaire responses which were provided by selected investigators after the site's first, third, and 5th procedure were reported.
Measured: Day 0 (Intra-surgery)
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback
Investigators were asked to answer a non-validated device questionnaire related to his/her experience using the ECHELON SLR. Questionnaire included following questions "satisfaction of operative flow compared to previous device and satisfaction of manipulation and repositioning compared to previous device" and each question response was ranged from 1 to 5 where 1=very dissatisfied, 2=dissatisfied, 3=neither dissatisfied nor satisfied (NDNS), 4=satisfied, 5=very satisfied, where higher response signified good satisfaction with the device. In this outcome measure, device questionnaire responses which were provided by selected investigators after the site's first, third, and fifth procedure were reported.
Measured: Day 0 (Intra-surgery)

Timeline

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

29 Sep 20208 Feb 2023

First posted10 Sep 2020
Study start29 Sep 2020
Primary completion17 Oct 2022
Study completion8 Feb 2023

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 Gastric ProceduresStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04544865
Sponsor's protocol ID: ESC_2018_03
Status last verified: Nov 2023
First submitted: 4 Sep 2020
Last updated: 5 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

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

Recruiting
Individually Tailored, Supervised, Remote Exercise Intervention to Improve Physical Function for Stage I-III Gastroesophageal Cancer Survivors, PRECISE Trial
Clinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
Active, not recruiting
Telehealth for the Self-Management of Dietary Quality of Life in Patients After Stomach Cancer Surgery
Gastric Carcinoma, Gastroesophageal Junction Adenocarcinoma
Not yet recruiting
Gastric String Test Combined With a Rapid Antigen Assay for Helicobacter Pylori Detection
Helicobacter Pylori
Active, not recruiting
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Gastritis Chronic, Gastroduodenitis
Not yet recruiting
Prophylactic PPI Use After EUS-GE Procedure
Malignant Gastric Outlet Obstruction

All Gastric Procedures trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Single-Arm, Multi-Center Study of the ECHELON ENDOPATH(TM) Staple Line Reinforcement Device in Gastric and Lung Resection Procedures
ClinicalTrials.gov ID: NCT04544865
Acronym / sponsor ID: ESC_2018_03
Conditions: Gastric Procedures, Lung Resection Procedures
Keywords: Buttress, gastrectomy, gastric bypass, lung volume reduction
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
Study start: 29 Sep 2020 (actual)
Primary completion: 17 Oct 2022 (actual)
Study completion: 8 Feb 2023 (actual)
First posted: 10 Sep 2020 (actual)
Results: Posted 5 Dec 2023

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Gastric and thoracic staple line reinforcement	Experimental	Device: Staple Line ReinforcementECHELON ENDOPATH Staple Line Reinforcement is used during a gastric or thoracic procedure.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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:
Willingness to give consent and comply with all study-related evaluations and visit schedule; and
At least 18 years of age.

Key exclusion criteria (11 listed)

Preoperative:
Physical or psychological condition which would impair study participation;
Body mass index (BMI) ≥ 46.0 kg/m2;
The procedure is a revision/reoperation for the same indication or same anatomical location;
A procedure where extended wound or organ support is required;

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
Staple Line ReinforcementENDOPATH ECHELON Staple Line Reinforcement is used for reinforcement of staple lines during lung resection and bariatric surgical procedures, according to instructions for use.	Device	Gastric and thoracic staple line reinforcement

Primary outcome

Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures
Time frame: From Day 0 (day of surgery) through 70 days post-surgery
Number of participants who experienced specific device-related AEs post gastric resection procedures was reported. Specific device-related AEs were bleeding (defined as occurrence of post-surgery blood transfusion deemed related to bleeding at the staple line or return to surgery room before 70-day post-surgery follow-up visit due to bleeding deemed related to the staple line), leak (defined as occurrence of intra-surgery or post-surgery gastrointestinal leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically), and stricture (defined as occurrence of stricture documented radiographically or by endoscopy along the staple line).
Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days
Time frame: From Day 0 (day of surgery) through 70 days post-surgery
Number of participants who experienced specific device-related AEs post lung resection procedures was reported. Specific device related AEs were prolonged air leak (occurrence of intra-surgery or post-surgery lung leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically) deemed related to the staple line (greater than post-surgery Day 7), and empyema (defined as purulent fluid collection in the pleural space documented radiographically, excluding chronic empyema).

3 secondary outcomes

Number of Study Devices Replaced During Surgery
Time frame: Day 0 (Intra-surgery)
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback
Time frame: Day 0 (Intra-surgery)
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback
Time frame: Day 0 (Intra-surgery)

Results and safety

Results posted to the registry on 5 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gastric Participants	109	98
Thoracic Participants	131	120

Primary outcome: Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures

Time frame: From Day 0 (day of surgery) through 70 days post-surgery. Count of participants. Unit: Participants

Measure	Gastric Participants n = 104
Bleeding	0
Leak	1
Stricture	0

Population analysed: The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure and completed the study through 70-days. Here, N' (number of participants analyzed) signifies the participants who were evaluable for this outcome measure. This outcome measure was planned to be analyzed for specified arm only.

Primary outcome: Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days

Time frame: From Day 0 (day of surgery) through 70 days post-surgery. Count of participants. Unit: Participants

Measure	Thoracic Participants n = 131
Prolonged air leak	0
Empyema	0

Population analysed: The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure and completed the study through 70-days. This outcome measure was planned to be analyzed for specified arm only.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 0 (Day of surgery) up to end of the study (2 years 4 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gastric Participants	8 of 109 (7.3%)	74 of 109 (67.9%)	0 of 109
Thoracic Participants	18 of 131 (13.7%)	116 of 131 (88.5%)	2 of 131

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Related trials for Gastric Procedures

Recruiting
Individually Tailored, Supervised, Remote Exercise Intervention to Improve Physical Function for Stage I-III Gastroesophageal Cancer Survivors, PRECISE Trial
Clinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
Active, not recruiting
Telehealth for the Self-Management of Dietary Quality of Life in Patients After Stomach Cancer Surgery
Gastric Carcinoma, Gastroesophageal Junction Adenocarcinoma
Not yet recruiting
Gastric String Test Combined With a Rapid Antigen Assay for Helicobacter Pylori Detection
Helicobacter Pylori
Active, not recruiting
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Gastritis Chronic, Gastroduodenitis
Not yet recruiting
Prophylactic PPI Use After EUS-GE Procedure
Malignant Gastric Outlet Obstruction

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.

Andrew Popoff, MD principal investigator

Henry Ford Health System

David Zeltsman, MD principal investigator

Long Island Jewish Medical Center

Andrew Wheeler, MD principal investigator

University of Missouri-Columbia

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

Questions about this trial

What is this clinical trial studying?

A study testing Staple Line Reinforcement in people with Gastric Procedures and Lung Resection Procedures, run by Ethicon Endo-Surgery at 8 sites in United States.

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 5 inclusion and 11 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 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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 5 Dec 2023). 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 Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures (time frame: From Day 0 (day of surgery) through 70 days post-surgery). The study lists 2 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 NCT04544865.

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 5 Dec 2023.