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Laparoscopic helium plasma coagulation (HELICA) for endemetriosis

Source agency:

AETSA

Date of Submission:

11/02/2010

Date of Printing:

05/02/2012

Disclaimer:

This report is work in progress and should not be used for external distribution without permission from the originating agency. Users should be aware that reports are based on information available at the time of research and often on a limited literature search.

Technology, Company & Licensing

Technology name:

Laparoscopic helium plasma coagulation (HELICA)

Technology - description:

Laparoscopic helium plasma coagulation of endometriosis is a minimally invasive surgery that use thermal ablation to destroy the affected tissue.
The Helica Thermal Coagulator is an instrument that combines low-pressure helium gas with low-voltage electrical power for the laparoscopic treatment of endometriosis

Company or developer:

Helica Instruments Ltd., Riccarton, Edinburgh, UK

Reason for database entry:

Minimaly invasive treatment for large patient group with significant morbidity.

Technology - stage in early warning process:

Assessment complete

Technology - stage of development:

Nearly established

Licensing, reimbursement and other approval:

Marketing authorization from FDA for HELICA TC

Technology - type(s):

Procedure

Technology - use(s):

Therapeutic

Patient Indication & Setting

Patient indications:

Endometriosis stages I to III (minimal to moderate).

Disease description and associated mortality and morbidity:

Endometriosis is a common condition. Women with endometriosis have deposits of endometrial tissue (usually confined to the lining of the uterus) outside the uterus. Many women are asymptomatic, although others may experience pelvic pain, dyspareunia, dysmenorrhoea or infertility. Endometriosis is a dynamic benign disease and the majority of women will not improve if left untreated.

Number of Patients:

Incidence and prevalence are difficult to establish. It is estimated to be present
in 10 – 15% of women of reproductive age. In women with pelvic pain or infertility, its reported incidence ranges from 20% to 90%.

Technology - specialities(s):

Gynaecology, women's sexual health, benign breast disease

Technology - setting(s):

None

Setting - further information:

 

Impact

Alternative and/or complementary technology:

Additive or complementary technology

Current Technology:

Analgesia and hormone treatment. Women with very severe symptoms may be offered more radical treatment with hysterectomy and removal of the ovaries.

Health Impact:

 

Diffusion:

Nearly established

Cost, infrastructure and economic consequences:

The machine costs £17,192, and the average cost per probe is £63.63. One probe is used per patient (1).

Ethical, social, legal, political and cultural impact:

 

Evidence & Policy

Clinical evidence and safety:

A systematic review was carried out. Fifty four potentially elegible publications were initially retrieved. Ten studies met all the inclusion criteria (population: endometiosis stages I-III; intervention: HELICA; and outcomes: effectiveness and safety) including one overview (2), one randomised clinical trial (1), and 8 case series.

Clinical trial (1): 35 women with history of pain were, upon confirmation of minimal to moderate endometriosis at diagnostic laparoscopy, randomised to immediate surgical or medical treatment (gonadotrophin-releasing hormone analogues). Women were symptom-free in 53% of cases in the HELICA group compared with 17% in the medical treatment group at 12 months of follow-up. An additional treatment was required in 29.5% and 66.5%, respectively.

Case series: Symptomatic relief was achieved in 25.3% of cases at 3 months of follow-up, and 90.3% at 14 months of follow-up. A repeat procedure was required in 16% and 18% of patients. Between 5% and 20% of patients required GnRh-a therapy at 6 months after HELICA treatment. Less than 50% of women who presented with infertility had conceived at the end of the trials.

Economic evaluation:

The average cost per patient in the surgical arm was £323.29 and in the medical arm was £918.12 (p<0.0001) (1).

Ongoing research:

None

Ongoing or planned HTA:

 

Web link:

 

References and sources:

(1) Lalchandani S, Baxter A, Phillips K. Is helium thermal coagulator therapy for the treatment of women with minimal to moderate endometriosis cost-effective? A prospective randomised controlled trial. Gynecol Surg 2005;2(4):255-8.

(2) National Institute for Health and Clinical Excellence. Interventional procedure overview of laparoscopic helium plasma coagulation of endometriosis. London: National Institute for Health and Clinical Excellence. 2009. Available at: http://www.nice.org.uk/nicemedia/pdf/ip/167%20-%20overview%20for%20web.pdf. Access: 2009-09-30.

Notes: