NCT07344935

Brief Summary

The Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique), intends for decrease the rate of gastroesophageal reflux disease (GERD). This study aims to evaluate the influence of the Nissen Sleeve technique on GERD. However, the Ezisurg easyEndoTM Linear Cutting Stapler and Loading Units for Single Use were used in this study, and its safety and performance could be evaluated at the same time.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

December 22, 2025

Last Update Submit

January 6, 2026

Conditions

Gastroesophageal Reflux Disease (GERD)

Outcome Measures

Primary Outcomes (1)

  • The rate of patients with GERD at 24 months

    The main objective of the study was to evaluate the impact of Sleeve Gastrectomy procedure with a Nissen fundoplication (Nissen-Sleeve) on the rate of patients with GERD at 24 months.

    24 months

Secondary Outcomes (7)

  • Surgery time

    Perioperative/Periprocedural

  • Intra-operation incidents

    Perioperative/Periprocedural

  • Hospital stays

    Perioperative/Periprocedural

  • Rate of re-intervention

    two-year

  • Rate of re-hospital

    two-year

  • +2 more secondary outcomes

Study Arms (2)

Ezisurg stapler

EXPERIMENTAL

easyEndoTM Lite Linear Cutting Stapler (U12L60) and Loading Units (N60G) manufactured by Ezisurg

Procedure: Ezisurg stapler SLEEVE technique

Ethicon Stapler

ACTIVE COMPARATOR

ECHELON™ Powered Stapler and reload (GST60G) manufactured by Johnson \& Johnson.

Procedure: Ethicon Stapler SLEEVE technique

Interventions

Ezisurg stapler SLEEVE techniquePROCEDURE

The Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique)

Ezisurg stapler
Ethicon Stapler SLEEVE techniquePROCEDURE

The Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique)

Ethicon Stapler

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index (BMI) ≥ 30 kg/m² (or BMI ≥ 27 kg/m² with at least one obesity-related comorbidity, e.g., type 2 diabetes, hypertension, dyslipidemia).
  • Medically eligible for laparoscopic sleeve gastrectomy (LSG) or Nissan sleeve surgery, as determined by a multidisciplinary bariatric team (e.g., surgeon, endocrinologist, dietitian).
  • Ability to understand and voluntarily sign written informed consent.
  • Willingness to comply with post-operative follow-up protocols (e.g., dietary monitoring, clinical visits, laboratory tests).

You may not qualify if:

  • BMI \< 30 kg/m² (or \< 27 kg/m² without obesity-related comorbidities).
  • Contraindications to laparoscopic surgery (e.g., severe abdominal adhesions, hemodynamic instability, uncorrected coagulopathy).
  • History of major gastrointestinal surgery (e.g., gastric bypass, colectomy) or anatomical abnormalities precluding sleeve gastrectomy.
  • Active or uncontrolled chronic diseases (e.g., end-stage renal disease, cirrhosis, metastatic cancer, severe cardiovascular disease).
  • Psychiatric disorders limiting adherence to post-operative care (e.g., severe depression, psychosis, substance use disorder).
  • Pregnancy or breastfeeding (or plans for pregnancy within 12 months post-surgery).
  • Allergy or intolerance to surgical materials, anesthesia, or post-operative medications required for the study.
  • Inability to communicate or cooperate with study procedures (e.g., language barriers, cognitive impairment).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Français du Levant

Montpellier, Hérault, 34295, France

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 15, 2026

Study Start

January 1, 2022

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)