Table 3.
Implantable gastric stimulator Transcend®: Studies summary
| Ref. | Type of research | Sample size, (enrolled/completed) | Mean age (yr) | Mean weight, (kg)/mean BMI (kg/m2) | Follow-up (mo) | Lifestyle change (required/advice given) | Baroscreen® |
| Korner et al[28], 2011 | Randomized + D, PC (SHAPE) | 13/13 | 48.8 | 113.1/40.6 | 24 | Y/Y | Y |
| Shikora et al[21], 2009 | Randomized + P, D, M, PC (SHAPE) | 190/180 | 43.9 | NR/41 | 12 | Y/Y | Y |
| Hoeller et al[73], 2006 | Non-randomized | 8/7 | 48.1 | 112.5/41.3 | 23 | NR/NR | N |
| Champion et al[29], 2006 | Non-randomized + O | 24/21 | 43 | 92/33 | 6 | Y/Y | Y |
| Miller et al[30], 2006 | Non-randomized + P, M (LOSS trial) | 91/25 | 41 | 116/41 | 24 | N/Y | Y |
| Shikora et al[20], 2005 | randomized + D, PC | 103/34 | 40 | 129/46 | 29 | NR/NR | N |
| (O-01 trial) | |||||||
| Shikora et al[20], 2005 | Non- randomized + O, M (DIGEST) | 30/23 | 39 | NR/42 | 24 | Y/Y | N1 |
| Cigaina et al[32], 2004 | Non- randomized | 65/NR | 39.4 ± 3.4 | 132.7 ± 27.3/46.9 ± 7.07 | 962 | Y/Y | NR1 |
| Favretti et al[74], 2004 | Non- randomized | 20/20 | 40 | 115/40.9 | 10 | N/Y | NR |
| De Luca et al[36], 2004 | Non- randomized + P (LOSS trial) | 69/20 | 41 | 115/41 | 15 | NR/NR | NR |
| Cigaina et al[75], 2003 | Non- randomized | 11/11 | 39.4 ± 3.4 | 121.7 ± 5.1/46.0 ± 2.5 | 8 | N/Y | NR |
| McCallum et al[35], 2002 | randomized + D | 103/NR | 40 | NR/46 | 12 | NR/NR | NR |
| D'Argent et al[76], 2002 | Non- randomized + P, O | 12/NR | 40.6 | 122.2/42.7 | 9 | NR/NR | NR |
1
No Baroscreen® conducted but binge eating assessment questionnaire and a psychological evaluation were carried out;
2
This study had four different cohorts over the 8-yr period, from 1996 to 2004.