Endoscopist and Endoscope Motions During Digestive Endoscopy

NCT ID: NCT03458403

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-29
• Study Completion Date: 2022-01-28

Brief Summary

The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements in flexible endoscopy.

Detailed Description

The increasing development of interventional digestive endoscopy raises the challenge to teach and learn complex endoscopic procedures. Nowadays experts are facing the challenge of explaining precisely an elaborate choreography of movements performed during the procedure, while novices are confronted with a broad range of hand, wrist and shoulder movements each resulting in different endoscope responses. The teaching strategy of endoscopy could benefit from a dedicated motion library that would associate the endoscopist's motion and the consequent endoscope response. A simplified endoscopic language made of individual motions could greatly shorten the learning curve.

The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements in flexible endoscopy.

Conditions

Scheduled Gastroscopy Under Sedation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Motions during gastroscopy

Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for.

Group Type: EXPERIMENTAL

Motions during gastroscopy

Intervention Type: PROCEDURE

Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for. The endoscope is removed halfway up the esophagus and inserted into the pylorus to the descending duodenum. The gesture is repeated three times.

Interventions

Motions during gastroscopy

Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for. The endoscope is removed halfway up the esophagus and inserted into the pylorus to the descending duodenum. The gesture is repeated three times.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient over 18 years old
• Patient who are scheduled for a gastroscopy procedure under sedation
• Patient able to understand the study and provide written informed consent
• Patient affiliated to the French social security system.

Exclusion Criteria

• Patient with an altered upper GI anatomy due to previous surgery
• Patient with a known anomaly of the upper GI anatomy
• Patient carrying an implantable medical device (pacemaker…)
• Patient with a condition preventing its participation to study procedures, according to investigator's judgment
• Pregnancy or breastfeeding
• Patient in custody
• Patient under guardianship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IHU Strasbourg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvana Perretta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

Locations

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, , France

Countries

France

References

Kranzfelder M, Wilhelm D, Doundoulakis M, Schneider A, Bauer M, Reiser S, Meining A, Feussner H. A probe-based electromagnetic navigation system to integrate computed tomography during upper gastrointestinal endoscopy. Endoscopy. 2014 Apr;46(4):302-5. doi: 10.1055/s-0033-1358814. Epub 2013 Nov 19.

Reference Type: BACKGROUND

PMID: 24254384 (View on PubMed)

Other Identifiers

2017-A01968-45

Identifier Type: OTHER

Identifier Source: secondary_id

17-001

Identifier Type: -

Identifier Source: org_study_id