Clinical Evidence

Precision-GI™ has been used in over 400 EUS-guided biopsy procedures performed at leading international endoscopy centers and its performance has been validated through several clinical trials.

EUS-SKYLINE: Live Case

“This will be very revolutionary for tissue quality”

Carlos Robles-Medranda, MD

Head of Endoscopy Services, IECED Medical Center

03  /  RESEARCH

Research

RESEARCH 01

Evaluation of a Novel Motorized EUS-FNB Device: A Prospective Pilot Study

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RESEARCH 02

Pilot study comparing a novel EUS-guided motorized biopsy needle technique with traditional sampling

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RESEARCH 03

Application of a novel endoscopic ultrasound–guided motorized fine needle for liver and pancreatic lesion biopsy

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FIH CLINICAL TRIAL

Precision-GI™ Technology vs. Leading Manual Needles*

 

PRECISION-GI™ EUS Biopsy

Manual EUS-FNB

Sampling Time

(Minutes)

PRECISION-GI™

3.87

(p=0.001)

FASTER

MANUAL

5.64

Total Procedure Average: Motorized Actuations vs. Manual Needle Actuations

PRECISION-GI™

5

(p=0.00002)

1/10 ACTUATIONS

MANUAL

55

Histology Score Average

(Scale of 1-5, 5 being the best)

PRECISION-GI™

4.6/5

(p=0.002)

HIGHER HISTOLOGY SCORE

MANUAL

3.2/5

* N=9. Dornblaser DW, Khamaysi I, Gross SA. Pilot study comparing a novel EUS-guided motorized biopsy needle technique with traditional sampling. IGIE. 2023 Apr 26;2(2):126-130. doi: 10.1016/j.igie.2023.03.005.

CLINICAL TRIAL  ·  IECED MEDICAL CENTER

Preliminary Results

 

 

 

PROSPECTIVE STUDY

40

patient prospective study

Conducted in patients with pancreatic masses and liver lesions

97.5%

Technical Success

 

 

 

 

 

 

 

 

 

 

95%

Adequate Samples

 

 

 

 

 

 

 

 

 

 

#

MEASUREMENT

PAIRED BARS

0%

25%

50%

75%

100%

VALUE

01

Lower Rate of Blood Contamination

25% vs. 65% with manual needles

 

Precision-GI™

 

 

 

 

25%

 

Manual needles

 

 

 

 

65%

02

Larger Core Fragments

30% of fragments >10mm vs. only 15% with manual needles

 

Precision-GI™

 

 

 

 

30%

 

Manual needles

 

 

 

 

15%

03

Excellent biopsy results

Average tumor content of ~70% vs. 10-20% with manual needles

 

Precision-GI™

 

 

 

 

~70%

 

Manual needles

 

 

 

 

10-20%

*Robles-Medranda, C., et al. (2025). Evaluation of a novel motorized EUS-guided fine-needle biopsy device and pathology quality parameters comparison to standard fine-needle biopsy: A prospective pilot study. Gastrointestinal Endoscopy, 101(5), S592–S593.