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Tissue Sealer

ENSEAL X1 Device for Surgical Procedures

N/A

Waitlist Available

Led By Keith Gersin, MD

Research Sponsored by Ethicon Endo-Surgery

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperative

Awards & highlights

Study Summary

This trial will look at the safety and effectiveness of a new device by collecting data from people who have it used on them during standard procedures.

Who is the study for?

This trial is for adults who need upper GI, lower GI, or gynecological surgery where blood vessels will be cut using the ENSEAL X1 Curved Jaw device. Participants must agree to follow study procedures and visits. Those with conditions affecting participation or in another clinical study that might interfere are excluded.Check my eligibility

What is being tested?

The ENSEAL X1 Curved Jaw Tissue Sealer is being tested across multiple centers during specific surgeries (upper/lower GI and gynecological). The goal is to collect data on its performance when used according to standard surgical practices and instructions.See study design

What are the potential side effects?

While not explicitly listed, potential side effects may include typical surgical risks associated with tissue sealers such as bleeding, infection at the incision site, pain at the sealing area, thermal injury to nearby tissues or organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intraoperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intraoperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Achievement of Grade 3 or lower hemostasis for each vessel transection

Secondary outcome measures

Distribution of 5-point scale scores for various tasks completed by the ENSEAL X1 Curved Jaw device (adhesiolysis, lymphatics or tissue bundles divided, tissue grasping, tissue cutting, or tissue dissection)

Distribution of hemostasis grading scale for each vessel transected

Type, name, and number of additional hemostasis products required to achieve hemostasis for Grade 4 vessel transections

Trial Design

1Treatment groups

Experimental Treatment

Group I: Upper Gastrointestinal/Lower Gastrointestinal/GynecologicalExperimental Treatment1 Intervention

Any upper gastrointestinal/lower gastrointestinal/gynecological procedure where the ENSEAL X1 Curved Jaw is used for vessel transection according to instructions for use.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ENSEAL X1 Curved Jaw

2021

N/A

~150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ethicon Endo-SurgeryLead Sponsor

83 Previous Clinical Trials

35,665 Total Patients Enrolled

Keith Gersin, MDPrincipal InvestigatorWake Forest University Health Sciences

4 Previous Clinical Trials

809 Total Patients Enrolled

James Hopkins, MDPrincipal InvestigatorSouthmead Hospital

Media Library

ENSEAL X1 Curved Jaw (Tissue Sealer) Clinical Trial Eligibility Overview. Trial Name: NCT04763421 — N/A

Upper Gastrointestinal, Lower Gastrointestinal, Gynecological Research Study Groups: Upper Gastrointestinal/Lower Gastrointestinal/Gynecological

Upper Gastrointestinal, Lower Gastrointestinal, Gynecological Clinical Trial 2023: ENSEAL X1 Curved Jaw Highlights & Side Effects. Trial Name: NCT04763421 — N/A

ENSEAL X1 Curved Jaw (Tissue Sealer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04763421 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently open to new participant enrollment?

"Clinicaltrials.gov states that this study is currently open for recruitment, which began on April 22nd 2021 and was most recently edited November 28th 2022."

Answered by AI

What is the uppermost limit of individuals involved in this research?

"Affirmative, the clinicaltrials.gov website confirms that this trial is presently recruiting individuals. The study was initially posted on April 22nd 2021 and most recently revisited November 28th 2022. A total of 164 participants are sought from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer in Select Procedures

2021. "A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer in Select Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04763421.