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CLINICAL TRIAL SUMMARIES
The HALO Ablation Technology System has been studied in clinical studies conducted since 2003:
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Human esophagectomy and animal studies demonstrated a consistent histological depth of ablation and uniformity of epithelium removal
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Dosimetry studies defined an effective energy dose and treatment parameters that minimize the risk of strictures
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Four-quadrant biopsy protocol every 1, 3, 6, and 12 months showed histological evidence of the resolution of intestinal metaplasia/dysplasia
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Complete eradication of non-dysplastic and dysplastic disease at rates exceeding 90% has been shown in numerous studies
Click on the title of the clinical study to learn more about it:
CLICK HERE FOR THE LIST OF CLINICAL INVESTIGATORS INVOLVED IN ONE OR MORE STUDIES EVALUATING THE HALO TECHNOLOGY
Complete Ablation of Esophageal Epithelium with a Balloon-based Bipolar Electrode:
A Phased Evaluation in the Porcine and in the Human Esophagus9
Evaluation of endoscopic and histological effects of healthy esophageal epithelium to determine dosimetry and safety parameters for future studies
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Endoscopic view showing acute appearance of ablation zone in human esophagus (12 J/cm2) |
Clinical trial completed, published in Gastrointestinal Endoscopy
Efficacy
- Energy delivery in < 1 second to the ablation zone
- Uniform and circumferential removal of esophageal epithelium achieved
- Consistent maximum depth to the muscularis mucosae using 10 J/cm2 or 12 J/cm2
Safe and well-tolerable procedure
- Stricture formation and submucosal injury in porcine specimens seen at higher settings of > 22 J/cm2
- No serious adverse events in the human patients: no perforation or submucosal injury
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Thin-Layer Ablation of Human Esophageal Epithelium Using a Bipolar Radiofrequency
Balloon Device10
Determined the optimal energy density settings and treatment parameters while evaluating histopathological endpoints when treating healthy human esophageal epithelium.
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Endoscopic view showing acute appearance of ablation zone |
Clinical Trial completed, published in Surgical Endoscopy
Efficacy
- Energy delivery in < 1 second to the ablation zone
- Use of H&E and blinded pathologist to evaluate results
- Complete removal of epithelium using 10 J/cm2 (2x) or 12 J/cm2 (1x/2x)
- Second (2x) application of energy did not significantly increase the depth of injury
- Maximum thickness of residual ablation after tissue slough was 35 µm
Safe and well-tolerable procedure
- No perforation and no pleural effusion
- Median procedure time 24 minutes
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Circumferential RF Ablation for Non-dysplastic Barrett's (NDBE) using the HALO
Ablation System (AIM Trial): Two and a Half Year Follow-up11
Phase I (AIM-I)
Evaluated safety, feasibility, tolerability, and dose response when ablating 2-3 cm segments of non-dysplastic intestinal metaplasia using randomized dosage
- Abstract presented at DDW 2005 and 2006
- Patient follow-up at 12 months
- One year data for AIM-I and AIM-II published in Gastrointestinal Endoscopy
Efficacy
- Complete clearance of IM in 67% of patients at 10 J/cm2 and 55% at 12 J/cm2 with residual IM being small islands
- Led to treatment settings for phase II of AIM trial
Safe and well-tolerable procedure
- Median procedure time 24 minutes
- Blinded pathologist determined no buried glands in over 1299 biopsies
- No strictures, perforations, nor pleural effusions
- Complete epithelial healing visible at follow-up endoscopy
Phase II (AIM-II)
Evaluates efficacy when ablating 2-6 cm segments of non-dysplastic intestinal metaplasia using circumferential ablation (HALO360 Ablation Catheter)
at baseline and at 4 months as needed and focal ablation (HALO90 Ablation Catheter) after 12 months for residual intestinal metaplasia.
- One year data for AIM-I and AIM-II published in Gastrointestinal Endoscopy
- Abstract presented at DDW 2006 and 2007
- Patient follow-up is 12 and 30 months
Efficacy
- Complete clearance of IM in 70% of patients at one year follow-up and 98.4% at two and a half year follow-up
Safe and well-tolerable procedure
- Median procedure time was 28 minutes for circumferential ablation and 27 for focal ablation
- Median VAS scores of < 30/100 with complete resolution by 3-4 days
- No buried glands, strictures, or serious adverse events at 12 and 30 months
- Complete epithelial healing visible at follow-up endoscopy
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Successful Circumferential Ablation of Barrett's esophagus (BE) with Low Grade Dysplasia (LGD): Two - Year Follow-up of the AIM-LGD Pilot Trial 23
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Post-procedure follow-up endoscopic image |
Assessed safety, efficacy, and tolerability when ablating 3-6 cm segments of low grade dysplasia using circumferential ablation (HALO360 Ablation
Catheter) at baseline and at 4 months as needed, incorporating focal ablation (HALO90 Ablation Catheter) after 12 months for residual diseased
epithelium.
- Abstract presented at DDW 2006 and 2007
- Patient follow-up was 24 months
Efficacy
- 100% of patients had complete resolution of low grade dysplasia and 90% had complete resolution of intestinal metaplasia at 24 months
Safe and well-tolerable procedure
- Median VAS scores of < 30/100 with complete resolution by 4-6 days
- No perforations or strictures
- Blinded pathologist determined no buried glands in > 450 biopsies
- Complete epithelial healing visible at follow-up endoscopy
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Endoscopic Ablation of Intestinal Metaplasia with High Grade Dysplasia (IM-HGD) in Esophagectomy
Patients Using a Balloon-based Ablation System13
To determine the optimal treatment parameters for the ablation of intestinal metaplasia with high grade dysplasia using randomized 10, 12, and 14 J/cm2
- Clinical Trial completed, published in Surgical Endoscopy
- Abstract presented at SAGES 2006
Conclusions of 11 treatment zones using H&E and microscopy
- 90% of treated segments had no evidence of high grade dysplasia
- No evidence of periesophageal or transmural thermal injury
- Maximum ablation depth was the lamina propria or muscularis mucosae
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Balloon-based Radiofrequency Ablation of Barrett's Esophagus in Patients with Low-Grade Dysplasia or High-Grade Dysplasia with and without a Prior Endoscopic Resection using circumferential and focal ablation24,25,27,28
Assessed the efficacy and safety of RF ablation in patients with BE containing LGD or HGD +/- prior endoscopic resection (ER). 4-10 cm segments of diseased
epithelium were treated using circumferential ablation (HALO360 Ablation Catheter) at baseline and every two months as needed, incorporating focal ablation
(HALO90 Ablation Catheter) for small residual areas.
This study also evaluated the effect of circumferential radiofrequency ablation on the internal diameter (ID) of the distal esophagus as assessed by a new
esophageal sizing device.
- Two abstracts presented at DDW 2006 and 2007
Conclusions
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96% of patients demonstrated complete remission of dysplasia and 90% had complete remission of intestinal metaplasia at a median follow-up of 6 months
after the last ablation
- One endoscopic resection related stenosis, resolved after 1 dilation
- No thermally-mediated strictures
- The recurrence rate of visible or histological Barrett’s esophagus was 0%
- There was no difference between baseline and post-ablation ID/compliance of the treated esophagus, suggesting that a functional esophagus
is preserved after this treatment
- Other potential applications of this sizing device may be the characterization of esophageal motility complaints and assessment of stricture
dilation results.
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Ablation of Intestinal Metaplasia Containing Dysplasia (AIM Dysplasia Trial): A Multi-Center, Randomized, Sham-controlled Trial
The study is the first to compare radiofrequency (RF) ablation therapy using the HALO and HALO technology to a current standard of care for Barrett's esophagus, which includes regular endoscopic biopsy surveillance and appropriate medical management of associated acid reflux disease (also called GERD).
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The clinical trial began March 2006 and includes 127 patients. Patients have been assigned in a 2:1 ratio to receive either an endoscopic ablation procedure
using the HALO Systems or a similar procedure in which no ablation is delivered (sham)
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Patients are not aware of which procedure they receive and will undergo follow-up with endoscopy and biopsy over the ensuing 12 months with comparison of the
treatment results at each time interval
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All patients receive esomeprazole magnesium as therapy for acid reflux disease as part of the study protocol. The study hypothesis, based on
available data from other trials, is that a significantly greater proportion of treatment patients versus sham-control patients will be completely free of
Barrett's esophagus at follow-up
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After one year, patients who received ablation therapy continue their follow-up for two full years, while patients who received the sham-control procedure will
undergo a "real" ablation procedure and will be followed for two additional years
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The participating 20 institutions and physicians represent a group of experienced gastroenterologists and general surgeons who are considered the leaders in
the field of Barrett's esophagus management:
| 1. Cleveland Clinic Foundation |
Gary Falk, M.D. |
| 2. Columbia University Medical Center |
Charles Lightdale, M.D. |
| 3. Dartmouth-Hitchcock Medical Center |
Richard Rothstein, M.D. |
| 4. University of Kansas, VAMC |
Prateek Sharma, M.D. |
| 5. GI Associates, Knoxville, TN |
Gene Overholt, M.D. |
| 6. Mayo Clinic, Rochester |
Kenneth Wang, M.D. |
| 7. Mayo Clinic, Jacksonville |
Herbert Wolfsen, M.D., Michael Wallace, M.D. |
| 8. Mayo Clinic, Scottsdale |
VK Sharma, M.D., David Fleischer, M.D |
| 9. Medical University of South Carolina |
Robert Hawes, M.D., Brenda Hoffman, M.D. |
| 10. Oregon Health Sciences University |
Glenn Eisen, M.D., Brian Fennerty, M.D., John Hunter, M.D. |
| 11. Tacoma Digestive Disease Research Center |
Michael Kimmey, M.D. |
| 12. Thomas Jefferson University |
Anthony Infantolino, M.D. |
| 13. University of Arizona, Southern Arizona VAMC |
Richard Sampliner, M.D. |
| 14. University of California, Irvine |
Kenneth Chang, M.D., Raman Muthasamy, M.D. |
| 15. University Hospitals of Cleveland |
Amitabh Chak, M.D. |
| 16. University of North Carolina, Chapel Hill |
Nicholas Shaheen, M.D. |
| 17. University of Texas, Southwestern, Dallas VAMC |
Ali Siddiqui, M.D., Stuart Spechler, M.D. |
| 18. VA Boston Healthcare |
Hiroshi Mashimo, M.D. |
| 19. Washington University, St. Louis |
Steven Edmundowicz, M.D. |
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References
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