Multicentric Study an Endoscopic Treatment of Digestive Neoplasia by Submucosal Dissection Evaluation of a New Water Jet System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system is a new water jet system which allows to perform Endoscopic submucosal dissection with a bifunctional catheter (injection and cutting).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Endoscopic Sub-mucosal Dissection With the Nestis® Jet Injector System With a Bi-functional Catheter: First Prospective Trial

NCT01913223

Barrett's Esophagus Intestinal Dysplasia Esophageal Dysplasia +1 more

COMPLETED NA

Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

NCT01378507

Digestive System Diseases

UNKNOWN NA

French Colorectal ESD Cohort in Experts Centers

NCT04592003

Cancer Colorectal Polyps Colorectal Endoscopic Submucosal Resection

RECRUITING

Endoscopic Submucosal Dissection for Early GI Neoplasia in the United Kingdom

NCT03039309

Endoscopic Submucosal Dissection

RECRUITING

Endoscopic Therapy for Laterally Spreading Tumors (LSTs)

NCT06464874

To Compare the Efficacy and Safety of Hybrid ESD and ESD in the Treatment of Colorectal LST

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Evaluation of the ability of this system to have a complete resection of superficial tumors of the digestive tract (that is to say a resection with free lateral and deep margins without residual tumor tissue)

Evaluation of the ability of such system to inject a viscous macromolecular solution of glycerol (glycerol mix: Glycerol 10 %, Fructose 5 %, saline solution 0.9%)(27. Fujishiro M, Yahagi N, Kashimura K, et al. Comparison of various submucosal injection solutions for maintaining mucosal elevation during endoscopic mucosal resection. Endoscopy. 2004;36:579-583.)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stomach Neoplasm Intestinal Neoplasm Rectal Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

endoscopic sub-mucosal dissection

Group Type EXPERIMENTAL

endoscopic sub-mucosal dissection

Intervention Type PROCEDURE

endoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

endoscopic sub-mucosal dissection

endoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* OVER 18 YEARS OLD
* PATIENTS AGREED WITH THE STUDY
* SCORE ASA 1 OR 2
* Patient recorded in a social safety organism
* patients presenting with superficial lesions with an endoscopic indication of resection

Exclusion Criteria

* under 18 years old
* Patients not agreed with the study
* pregnant women
* patient included in an another study
* medical treatments (radiotherapy, surgery endoscopis treatements) before the intervention
* coagulation disorders
* score asa over 3
* patients with another neoplasic lesion

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No