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Disponibel endoskopplattform i tredje roms endoskopiske prosedyrer

29. september 2026 oppdatert av: Mohamed Othman, MD, Baylor College of Medicine

Prospektiv pilotforsøk for å demonstrere effektiviteten, gjennomførbarheten og sikkerheten til en endoskopplattform til engangsbruk i endoskopiske prosedyrer for tredje rom

This is a prospective, single-arm unblinded study performed at a single tertiary center in the United States. All subjects will receive standard medical care and no experimental interventions are going to be performed. The procedures will be performed by Dr. Mohamed Othman, Dr. Salmaan Jawaid, Dr. Tara Keihanian, and Dr. Fares Ayoub. All patients undergoing third space endoscopic procedures including e-POEM and g-POEM, meeting study inclusion criteria will be screened by study coordinators for preliminary eligibility and those who meet the inclusion criteria will be approached individually for further discussion about the study and obtaining informed consent.

The goal of this prospective, pilot trial is to demonstrate the efficacy, feasibility, safety, and clinical outcomes of third space endoscopic procedures completed using a disposable endoscope platform.

Studieoversikt

Detaljert beskrivelse

Over the past decade, therapeutic endoscopy has rapidly progressed giving rise to the fields of third space endoscopy and endoscopic surgery. In the foregut, esophageal per-oral endoscopic myotomy (e-POEM) has become the standard approach for achalasia with level I data supporting its use1. For gastroparesis, randomized clinical trial data 2 now supports gastric POEM (g-POEM) use for refractory cases with promising results particularly in diabetic and post-surgical patients.

Despite the remarkable advances in endoscopic therapy, there has been comparably slower progress in innovation for endoscopic platforms. In fact, current endoscope design is not significantly different from the earliest endoscopes where tip deflection is primarily controlled by rotating dials on the shaft of the endoscope and insufflation and suction are controlled by manual pressure-controlled buttons. Original fiberoptic gastroscopes were designed to facilitate diagnostic use, where the endoscopist manipulates tip-deflection dials using both hands while viewing the intestinal mucosa through a viewer, with an assistant moving the shaft of the endoscope. This same design was then adapted for colonoscopy, and later for duodenoscopy and endoscopic ultrasound. Despite significant progress in image quality, the endoscope remains a heavy device, requiring significant dexterity and musculoskeletal fitness on behalf of the endoscopist to perform endoscopy ergonomically without risking muscle injury. In addition, endoscopes require several supportive devices to function, including a separate water pump, video processor, computer screen and if needed an electrosurgical generator, making the portability of traditional endoscopic platforms quite limited.

More recently, rising concerns about infectious complications from reusable endoscopes have led to the development of several single-use endoscope platforms. A novel disposable endoscope (AMBU single-use disposable gastroscope; AMBU USA, Columbia, Md, USA) was recently approved by the U.S. Food & Drug Administration (FDA) in 2022 for use in humans. This endoscopic platform is designed for single use and comes with several advantages compared to traditional reusable endoscopes. The platform is significantly lighter, with a weight of 650 grams compared to a traditional reusable upper endoscope which weighs approximately 3900 grams. Additionally, the single use platform has a wider depth of field and significantly smaller video processor and built in portable screen. These advantages have led our group to use the endoscope for therapeutic foregut procedures including e-POEM and g-POEM with positive results. The investigators at Baylor College of Medicine most recently published a proof-of-concept experience 3 in using the disposable gastroscope for a case of e-POEM, where the significantly lighter weight of the endoscope allowed easier maneuverability and subjectively lower musculoskeletal strain for the performing endoscopist, with no negative effects on image quality or technical aspects of the procedure.

Before wider adoption, these perceived benefits need to be demonstrated in a larger, prospective trial confirming non-inferiority to historical data from reusable platforms and safety.

Studietype

Observasjonsmessig

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Texas
      • Houston, Texas, Forente stater, 77030
        • Baylor College of Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

All patients 18 years or older, not pregnant (if a woman), consenting to the study, and presents for an Esophageal POEM, or Gastric POEM will be invited to participate on this study.

Beskrivelse

Inclusion Criteria:

  1. Patient is ≥ 18 years old.
  2. Patients can provide informed consent.
  3. Patient is referred for third space endoscopic procedure including e-POEM, g-POEM.

Exclusion Criteria:

  1. Patient is < 18 years old.
  2. Patient refused and/or unable to provide consent.
  3. Patient is a pregnant woman.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: CASE_ONLY
  • Tidsperspektiver: PROSPECTIVE

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Technical Success
Tidsramme: Day 1 (procedure day)

Defined as the ability to perform entire myotomy (procedure) with the disposable endoscope.

Day 1 (procedure day)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total Procedure Time
Tidsramme: During Procedure

Total recorded time to perform procedure using disposable endoscope

During Procedure
Intraprocedural adverse events
Tidsramme: During Procedure

Adverse events emerging during procedure

During Procedure
Satisfactory scores on Endoscopist satisfaction
Tidsramme: Immediately following completion of the procedure

Satisfactory survey: with endoscope maneuverability (1-5 Likert scale; 1 being "strongly disagree" to 5 being "strongly agree"), with endoscope functionality [insufflation, suction, accessory passage] (1-5 Likert scale), with endoscope image quality (1-5 Likert scale; 1 being "strongly disagree" to 5 being "strongly agree").

Immediately following completion of the procedure
Scores on musculoskeletal strain survey
Tidsramme: Immediately following completion of the procedure

Musculoskeletal Strain survey: Focused on Overall strain, wrist strain, shoulders strain, and neck strain

Immediately following completion of the procedure

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Mohamed Othman, MD, Baylor College of Medicine

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. desember 2026

Primær fullføring (Antatt)

30. september 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

26. august 2024

Først innsendt som oppfylte QC-kriteriene

13. desember 2024

Først lagt ut (Faktiske)

17. desember 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

There are no plans to share IPD to other researchers.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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