Evidence map›Paper›PMID 40897881›Full record

Trial reportSurgical endoscopy2025

Fluorescence-guided sleeve gastrectomy and gastric bypass: first-in-human trial using novel gastric calibration tube.

Salim Abunnaja, Diane Bronikowski, Acara Turner, Nova Szoka, Rebekah Guillow, Stephanie Cox, Lawrence Edward Tabone

Erratum issued Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Surgical endoscopy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05486325 (Pilot Study of the Endolumik Gastric Calibration Tube for Bariatric Surgery), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05486325 naunknown statusnot on this map

Pilot Study of the Endolumik Gastric Calibration Tube for Bariatric Surgery

TypeinterventionalSponsorEndolumik, IncRan2022 to 2022Enrolled30ConditionsMorbid ObesityArmsEndolumik Gastric Calibration Tube (EGCT)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Salim AbunnajaDepartment of Surgery, West Virginia University School of Medicine, Suite 7500 HSS, PO Box 9238, Morgantown, WV, WV 26506-9238, USA.
Diane BronikowskiDepartment of Surgery, West Virginia University School of Medicine, Suite 7500 HSS, PO Box 9238, Morgantown, WV, WV 26506-9238, USA.
Acara TurnerDepartment of Surgery, West Virginia University School of Medicine, Suite 7500 HSS, PO Box 9238, Morgantown, WV, WV 26506-9238, USA.
Nova SzokaDepartment of Surgery, West Virginia University School of Medicine, Suite 7500 HSS, PO Box 9238, Morgantown, WV, WV 26506-9238, USA.
Rebekah GuillowDepartment of Anesthesia, West Virginia University School of Medicine, Morgantown, WV, USA.
Stephanie CoxDepartment of Behavioral Medicine and Psychiatry, West Virginia University School of Medicine, Morgantown, WV, USA.
Lawrence Edward TaboneDepartment of Surgery, West Virginia University School of Medicine, Suite 7500 HSS, PO Box 9238, Morgantown, WV, WV 26506-9238, USA. letabone@hsc.wvu.edu.ORCID http://orcid.org/0000-0001-6839-2758

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFluorescence-guided surgery employs a near-infrared emitting dye or light source to enhance intraoperative visualization. This study reports the first-in-human application of the Endolumik fluorescence-guided calibration tube (EGCT) during laparoscopic sleeve gastrectomy (SG) and gastric bypass (GB).

methodsUnder IRB approval (NCT05486325), two surgeons performed 21 laparoscopic SG and 10 GB procedures using EGCT. Evacuation of gastric contents, gastric sleeve/pouch calibration, and leak testing were performed. Surgical and anesthesia providers completed surveys evaluating their EGCT experience.

resultsNo device-related adverse events occurred. EGCT was used by 10/5 unique surgical team members during SG/GB, respectively, and by 20/5 anesthesia providers. All surgical team members rated device experience as good or very good compared to the standard bougie. Visualization during gastric sleeve construction was rated as good or very good, and very good for gastric pouch construction. All surgical members reported confidence in the device enabling consistent gastric sleeve or pouch sizing. EGCT increased surgeon confidence level for device introduction during GB. Among anesthesia providers, 84% rated their experience during SG with the device as good or very good, including 89.5% of CRNAs. Additionally, 75%/90% of SG/GB clinicians believed the device reduced the likelihood of adverse events compared to standard devices. The average likelihood to recommend the EGCT was 9 out of 10 among surgeons.

conclusionEGCT improved visualization during gastric sleeve and pouch construction and increased confidence during device introduction for GB; surgeons would recommend the device to colleagues. Further research is needed to assess the impact on clinical outcomes.

Indexed as

GastrectomyGastric BypassLaparoscopyObesity, MorbidOptical ImagingSurgery, Computer-AssistedAdultCalibrationFemaleHumansMaleMiddle AgedBariatric surgeryBougieCalibration tubeFluorescence-guided surgeryGastric bypassSleeve gastrectomy

Identifiers

PMID40897881

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.