The DEXTER-assisted Non-Emergent and Acute cholecyStecTom... | NCT06473688

Studies
The DEXTER-assisted Non-Emergent and Acute cholecyStecTomy Study (The NEST Study)

NCT06473688

Sponsor

Distalmotion SA

Status

Completed

Last Update Posted

Feb 10, 2025Actual

Enrollment

51Actual

Phase

Not provided

Conditions

Cholecystectomy

Interventions

Cholecystectomy

Countries

France
Germany
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 21, 2024Actual

Primary Completion Date

Dec 30, 2024Actual

Completion Date

Dec 30, 2024Actual

First Submitted Date

Jun 19, 2024

First Submission Date that Met QC Criteria

Jun 19, 2024

First Posted Date

Jun 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2025

Last Update Posted Date

Feb 10, 2025Actual

Name	Class
Confinis	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic cholecystectomy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cholecystectomy	Procedure	Robotic-assisted and laparoscopic cholecystectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
primary safety endpoint	occurrence of Clavien - Dindo grades III-V adverse events	up to 30 days
primary performance endpoint	successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach	intraoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged > 18 years
Patients planned to undergo elective robot-assisted and laparoscopic cholecystectomy; using one camera port, two ports for the manipulating instruments, and additional ports as needed.

Exclusion Criteria:

Morbidly obese patients (BMI > 40)
Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
Bleeding diathesis
Pregnancy
Patients with pacemakers or internal defibrillators
Any planned concomitant procedures
Patient deprived of liberty by administrative or judicial decision
Participation in another interventional clinical trial

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients undergoing a cholecystectomy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Saintes - Saint-Jean-d'Angély		Saintes		17100	France
Universitätsklinikum Bonn

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002763	Cholecystectomy

Ancestor Terms

ID	Term
D001662	Biliary Tract Surgical Procedures
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided