Clinical Evidence

The Evidence
for Pathfinder®

Video Case Reports on our Overtube Control Looping

intraductal papillary mucinous neoplasm video

Video: Endoscopic treatment of a large intraductal papillary mucinous neoplasm of the bile duct: tips and tricks learned during multiple treatments of a difficult case

Video GIE
Ibrahim Yaghnam, MD; Nauroz Syed, MD, MHS; June Peng, MD; Matthew Moyer, MD, FASGE. Video GIE. 2023; Online Feb 06, 2023

submucosal dissection

Video: Combination of a dynamic rigidizing overtube and a novel injectable needle-type knife to facilitate colorectal endoscopic submucosal dissection

Video GIE
Martin Coronel, MD; Emmanuel Coronel, MD; Laura Romero, MBA; Phillip S. Ge, MD. Video GIE. 2021; Online April 05, 2021

Video: Use of a Novel Dynamic Rigidizing Overtube in Difficult Colonoscopy Due to Looping

Video GIE
Mike T. Wei, MD; Joo Ha Hwang, MD, PhD; Rabindra Watson, MD, Shai Friedland, MD. Video GIE. 2020; Vol 5: 11, 583-585

Video: Use of a Rigidizing Overtube for Altered Anatomy ERCP

Video GIE
Mike T. Wei, MD; Shai Friedland, MD; Rabindra Watson, MD; Joo Ha Hwang, MD, PhD. Video GIE. 2020; Online Sept 29, 2020

Case Reports

Endoscopic Retrograde Cholangiopancreatography After Pancreatico-duodenectomy and the Utility of Rigidizing Overtube in Improving Procedural Success – A Tertiary Cancer Center Experience

American College of Gastroenterology Annual Conference – Poster

October 2022

Abstract
Endoscopic retrograde cholangiopancreatography (ERCP) remains a challenge in patients with a pancreaticoduodenectomy (PD). Advances in endoscopic technology may improve success of the ERCP after PD. Herein we report outcomes of ERCP after PD at a tertiary cancer center. We also summarize our experience with the use of a novel rigidizing overtube (RO) for ERCP post- PD.

Use of novel rigidizing overtube for endoscopic submucosal dissection (esd) of colonic lesions: a multicenter matched study

Disease Digestive Week – Poster

May 2022

Abstract

Endoscopic submucosal dissection (ESD) in the colon is a technically challenging procedure. Poor scope maneuverability and loop formation are one of the primary reasons for failure of colonic ESD. The novel Rigidizing Overtube (RO) (Pathfinder; Neptune Medical, USA) has been reported to be useful to prevent loop formation during colonoscopy. Once the overtube has been advanced to the desired location, application of a vacuum stiffens the overtube which allows the endoscope to advance through the overtube without loop formation in the region where the overtube has traversed.

Successful Use of a Novel Dynamic Rigidizing Overtube in a Patient with Looping and Bradycardia during Colonoscopy

American College of Gastroenterology Annual Conference – Poster

October 2020

Abstract

In this case of a 72 year old patient, a surveillance colonoscopy was unable to be advanced beyond the ascending colon due to looping. Attempts to advance the scope further caused bradycardia down to a heart rate in the 40’s, despite abdominal pressure and position change. Pathfinder was placed on the scope and advanced through the ascending colon in its flexible scope, then rigidized. It allowed for easy cecal intubation and successful completion of the colonoscopy without any loop formation.

Altered Anatomy ERCP Using a Novel Dynamic Rigidizing Overtube

American College of Gastroenterology Annual Conference – Poster

October 2020

Abstract

A 42 year-old patient with a history of iatrogenic bile duct transection during cholecystectomy underwent HJ; HJ stricture required balloon-assisted enteroscopy with ERCP to place a stent. The stent was removed after three months but restricturing occurred leading to left-sided intrahepatic stone disease. As a result, multiple antegrade double balloon enteroscopies were required to treat accessible intrahepatic stones, but several remained and could not be accessed due to difficult angulation and looping. Pathfinder was used to advance to the HJ without looping in the stomach and provided improved control up the ascending PB limb. A stone extraction balloon was then able to remove the bilary duct stones; imaging confirmed stone remove and bile duct clearance. The clinical team suggested that the device may be useful in other altered anatomy ERCP cases when anterograde approaches fail and a luminal approach is required.

Providing Stability to Your Work – a Novel Rigidizing Overtube Facilitates Complex Underwater EMR of a 7-cm Ascending Polyp

American College of Gastroenterology Annual Conference – Poster

October 2020

Abstract

In the case of an 85 year-old patient with a large ascending colon polyp (7cm x 4cm), the site was difficult to reach with conventional colonoscopy methods due to looping of the patient’s long colon. Pathfinder greatly assisted with stability during piecemeal underwater EMR of the lesion. The clinical team reported that the stability the overtube provided, combined with its adaptive flexibility, allowed for easy insertion and secure positioning for a complex endoscopic procedure.

Clinical Studies on our Control Looping Enteroscopy

A Novel Dynamic Rigidizing Overtube Significantly Eases Difficult Colonoscopy

American College of Gastroenterology Annual Conference – Poster

October 2020

Abstract

This was a six month, single-center study of Pathfinder used in 14 difficult colonoscopy cases. In the 8 cases that previously experienced looping that prevented reaching the cecum despite position change and abdominal counter pressure, use of Pathfinder enabled all cases to be salvaged and cecum was reached. In the 6 cases where poor stabilization of the endoscope prevented therapeutic polypectomy, Pathfinder enabled successful completion of polypectomy in all cases. Endoscopists rated the exertion level before and after Pathfinder using a TLX weighted score – for previous looping cases the TLX score decreased from mean 81.1 to 26.0, and for previous failed polypectomy cases the TLX score decreased from mean 79.7 to 40.4.

Enteroscopy Enabled Using a Novel Dynamic Rigidizing Overtube: An Initial Single-Center Experience

American College of Gastroenterology Annual Conference – Poster

October 2020

Abstract

This was a retrospective, six-month study of 12 enteroscopy cases – 9 retrograde and 3 antegrade. Endoscopists reported significant ease of enteroscopy compared to traditional, double-balloon methods in both retrograde and antegrade procedures, with lower perceived physical and mental demands. There were no complications associated with use of the device.

Novel Rigidizing Overtube for Colonoscope Stabilization and Loop Prevention

Gastrointestinal Endoscopy (GIE) – Journal Article

July 2020

Abstract

An initial experience in 29 patients using the Pathfinder overtube demonstrated that 100% of previously incomplete colonoscopies were able to be completed using Pathfinder. The median cecal intubation time in lower endoscopy cases was 5 minutes.

Novel Rigidizing Overtube for Enteroscope / Colonoscope Stabilization and Loop Prevention

Gastrointestinal Endoscopy (GIE) – Poster

June 2020

Abstract

Loop formation can impede scope advancement, destabilize the tip and cause pain. Strategies to mitigate looping include torque-based reduction maneuvers, variable stiffness shafts and abdominal splinting. In some cases, these strategies are insufficient and there is a need for novel instruments.