P4578 - Qualitative Comparison of Air-Charged and Solid-State HRAM Catheter Normative Values in Healthy Subjects

Kamran Ayub, MD, MRCP¹, Satish SC. Rao, MD, PhD, FACG², Allan Weston, MD, FACG³, Karlo Fidel, MD², Delaram Asadi, MD², Danielle Long, BS²
1Southwest Gastroenterology, a Division of GI Partners of Illinois, Oak Lawn, IL; 2Augusta University Medical Center, Augusta, GA; 3Digestive Health Center of the Four States, LLC, Joplin, MO

Introduction: While high-resolution anorectal manometry (HRAM) is essential for evaluating anorectal function, absolute pressure values can vary substantially depending on the catheter type. Air-charged and solid-state catheters differ in construction, transduction mechanism, and calibration method—each influencing recorded values. This variability necessitates catheter-specific interpretation. As a secondary objective of the ILLUMINATE study, we compared normative data from a novel 10-Channel Air-Charged Disposable High-Resolution Anorectal Manometry (HRAM) Catheter (Solar™ catheter) to published values from solid-state systems to assess qualitative agreement and highlight device-specific considerations.

Methods: The ILLUMINATE study was a prospective, multi-center, open-label trial wherein all subjects underwent standardized HRAM using a novel 10-channel air-charged disposable HRAM catheter per IAPWG protocol and London Classification, and a subset also underwent testing with the solid-state (UniTip™) catheter (n=30). Parameters collected included: anal resting pressure, squeeze pressure, cough pressure, and functional anal canal length. Values were descriptively compared to published normative datasets from solid-state catheter systems.

Results: There were 30 subjects (3 males, 37 females; mean age = 39 ± 9 years) who underwent both novel 10-channel air-charged disposable catheter and solid-state catheter ARM studies. Anal resting pressures recorded with the air-charged catheter were approximately equivalent to solid-state reference values. Functional anal canal length measurements were consistent across technologies as well. See Table 1 details.

Discussion: Minor differences were observed between air-charged and solid-state HRAM catheters, but in general physiologic trends were preserved across systems. These findings underscore the importance of using catheter-specific normative values when interpreting HRAM results and reinforce that direct numeric comparison between devices may not be valid. The novel 10-Channel Air-Charged Disposable High-Resolution Anorectal Manometry (HRAM) Catheter demonstrated consistent performance and clinical utility within its calibrated reference range.


Figure: Table 1. Qualitative Comparison of Air-Charged (n=30) vs. Solid-State (n=30) Normative Values

Disclosures:
Kamran Ayub: Laborie Medical Technologies – Grant/Research Support.
Satish Rao: Laborie Medical Technologies – Grant/Research Support. Vibrant Ltd – Advisory Committee/Board Member.
Allan Weston: Laborie Medical Technologies – Grant/Research Support.
Karlo Fidel indicated no relevant financial relationships.
Delaram Asadi indicated no relevant financial relationships.
Danielle Long indicated no relevant financial relationships.

Kamran Ayub, MD, MRCP¹, Satish SC. Rao, MD, PhD, FACG², Allan Weston, MD, FACG³, Karlo Fidel, MD², Delaram Asadi, MD², Danielle Long, BS². P4578 - Qualitative Comparison of Air-Charged and Solid-State HRAM Catheter Normative Values in Healthy Subjects, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.