Early Esophagogastroduodenoscopy Performed Bedside Using Single-use Disposable Endoscope

NCT07033286 | Completed

• 1 other identifier: BedsideGAS_pilot
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

We aim to evaluate whether the use of single-use gastroscopes at the bedside can reduce the time from clinical indication to procedure compared to reusable gastroscopes used in the endoscopy unit for patients referred for subacute gastroscopy. Participants in the first period will be scheduled for gastroscopy with a reusable gastroscope in the endoscopy unit, whereas participants during the second period will have a gastroscopy performed at the hospital department (bed-side) with a single-use gastroscope.

Conditions

Upper Gastrointestinal Disorder

Keywords

Gastroscopy; Upper endoscopy; Gastroscope; Esophagogastroduodenoscope; Single-use; Reusable; Bedside

Outcome Measures

Primary Outcomes (2)

• Time from the indication/decision for early endoscopy to procedure

  From indication to procedure, up to two weeks

• Endoscopists' rating of the gastroscope

  The endoscopists' rating of the gastroscope

  Immediately after procedure

Secondary Outcomes (8)

• Time from admission to procedure

  From admission to procedure, up to 3 months

• Time from procedure to discharge

  From procedure to discharge, up to 3 months

• Duration of the procedure

  During the procedure

• Did the patient need sedation or local anaesthetic throat spray?

  During the procedure

• Technical success

  From admission to discharge, up to 3 months

Study Arms (2)

Reusable gastroscope in the endoscopy unit

ACTIVE COMPARATOR

In the first period the subacute gastroscopies will be performed with a reusable gastroscope in the endoscopy unit.

Device: Diagnostic gastroscopes, Olympus

Single-use gastroscope bedside in the patient's room

EXPERIMENTAL

In the second period the subacute gastroscopies will be performed with a reusable gastroscope in bedside in the patients' rooms.

Device: Ambu aScope Gastro

Interventions

Ambu aScope Gastro DEVICE

CE-marked single-use gastroscopes from Ambu are used in the single-use group.

Single-use gastroscope bedside in the patient's room

Diagnostic gastroscopes, Olympus DEVICE

Reusable gastroscopes from Olympus are used in the reusable group.

Reusable gastroscope in the endoscopy unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of any gender, 18 years of age or older
• Diagnostic EGD without general anaesthesia

You may not qualify if:

• ASA-score of 4 or higher
• Unstable patient
• Suspicion of active bleeding
• Anticoagulants not withheld due to regional guidelines

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital

Køge, 4600, Denmark

Location

Related Publications (8)

• Slivka A, Ross AS, Sejpal DV, Petersen BT, Bruno MJ, Pleskow DK, Muthusamy VR, Chennat JS, Krishnamoorthi R, Lee C, Martin JA, Poley JW, Cohen JM, Thaker AM, Peetermans JA, Rousseau MJ, Tirrell GP, Kozarek RA; EXALT Single-use Duodenoscope Study Group. Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity. Gastrointest Endosc. 2021 Dec;94(6):1046-1055. doi: 10.1016/j.gie.2021.06.017. Epub 2021 Jun 26.

  PMID: 34186052 BACKGROUND

• Muthusamy VR, Bruno MJ, Kozarek RA, Petersen BT, Pleskow DK, Sejpal DV, Slivka A, Peetermans JA, Rousseau MJ, Tirrell GP, Ross AS. Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2108-2117.e3. doi: 10.1016/j.cgh.2019.10.052. Epub 2019 Nov 6.

  PMID: 31706060 BACKGROUND

• Bai Z, Wang R, Cheng G, Ma D, Ibrahim M, Chawla S, Qi X. Outcomes of early versus delayed endoscopy in cirrhotic patients with acute variceal bleeding: a systematic review with meta-analysis. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e868-e876. doi: 10.1097/MEG.0000000000002282.

  PMID: 35048654 BACKGROUND

• Gralnek IM, Camus Duboc M, Garcia-Pagan JC, Fuccio L, Karstensen JG, Hucl T, Jovanovic I, Awadie H, Hernandez-Gea V, Tantau M, Ebigbo A, Ibrahim M, Vlachogiannakos J, Burgmans MC, Rosasco R, Triantafyllou K. Endoscopic diagnosis and management of esophagogastric variceal hemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2022 Nov;54(11):1094-1120. doi: 10.1055/a-1939-4887. Epub 2022 Sep 29.

  PMID: 36174643 BACKGROUND

• Jeong N, Kim KS, Jung YS, Kim T, Shin SM. Delayed endoscopy is associated with increased mortality in upper gastrointestinal hemorrhage. Am J Emerg Med. 2019 Feb;37(2):277-280. doi: 10.1016/j.ajem.2018.05.049. Epub 2018 May 24.

  PMID: 29848459 BACKGROUND

• Siau K, Hodson J, Ingram R, Baxter A, Widlak MM, Sharratt C, Baker GM, Troth T, Hicken B, Tahir F, Magrabi M, Yousaf N, Grant C, Poon D, Khalil H, Lee HL, White JR, Tan H, Samani S, Hooper P, Ahmed S, Amin M, Mahgoub S, Asghar K, Leet F, Harborne MJ, Polewiczowska B, Khan S, Anjum MR, McFarlane M, Mozdiak E, O'Flynn LD, Blee IC, Molyneux RM, Kurian A, Abbas SN, Abbasi A, Karim A, Yasin A, Khattak F, White J, Ahmed R, Morgan JA, Alleyne L, Alam MA, Palaniyappan N, Rodger VJ, Sawhney P, Aslam N, Okeke T, Lawson A, Cheung D, Reid JP, Awasthi A, Anderson MR, Timothy JR, Pattni S, Ahmad S, Townson G, Shearman J, Giljaca V, Brookes MJ, Disney BR, Guha N, Thomas T, Norman A, Wurm P, Shah A, Fisher NC, Ishaq S, Major G. Time to endoscopy for acute upper gastrointestinal bleeding: Results from a prospective multicentre trainee-led audit. United European Gastroenterol J. 2019 Mar;7(2):199-209. doi: 10.1177/2050640618811491. Epub 2018 Oct 28.

  PMID: 31080604 BACKGROUND

• Garg SK, Anugwom C, Campbell J, Wadhwa V, Gupta N, Lopez R, Shergill S, Sanaka MR. Early esophagogastroduodenoscopy is associated with better Outcomes in upper gastrointestinal bleeding: a nationwide study. Endosc Int Open. 2017 May;5(5):E376-E386. doi: 10.1055/s-0042-121665.

  PMID: 28512647 BACKGROUND

• Gralnek IM, Stanley AJ, Morris AJ, Camus M, Lau J, Lanas A, Laursen SB, Radaelli F, Papanikolaou IS, Curdia Goncalves T, Dinis-Ribeiro M, Awadie H, Braun G, de Groot N, Udd M, Sanchez-Yague A, Neeman Z, van Hooft JE. Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2021. Endoscopy. 2021 Mar;53(3):300-332. doi: 10.1055/a-1369-5274. Epub 2021 Feb 10.

  PMID: 33567467 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Mustafa Bulut

  Surgical department of Zealand University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, quality assurance study. Non-randomized, controlled single center feasibility study. Comparing a period where subacute gastroscopies are performed in the endoscopy unit (reusable gastroscopes) with a period where they are performed bedside in the patients room (single-use gastroscopes).

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 24, 2025
• Study Start: June 5, 2023
• Primary Completion: June 13, 2024
• Study Completion: July 13, 2024
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)